Part A- Time to Reach Maximum Observed Plasma Concentration (Tmax) for Total-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Tmax for Total-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-t) for OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-t) for OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-24) for OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-24) for OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Cmax for OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Cmax for OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Average Ctrough for OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 17, 18 and 19 has been presented.
Part A- Average Ctrough for OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 35, 36, 37 and 38 has been presented.
Part A- Tmax for OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Tmax for OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-t) for Tauro-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-t) for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-24) for Tauro-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-24) for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Cmax for Tauro-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Cmax for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Average Ctrough for Tauro-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 17, 18 and 19 has been presented.
Part A- Average Ctrough for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 35, 36, 37 and 38 has been presented.
Part A- Tmax for Tauro-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Tmax for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-t) for Glyco-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-t) for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-24) for Glyco-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- AUC(0-24) for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Cmax for Glyco-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Cmax for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Average Ctrough for Glyco-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 17, 18 and 19 has been presented.
Part A- Average Ctrough for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 35, 36, 37 and 38 has been presented.
Part A- Tmax for Glyco-OCA: OCA Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part A- Tmax for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Part B- Tmax for Total-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Part B- Tmax for Total-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Part B- AUC(0-t) for OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- AUC(0-t) for OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- AUC(0-24) for OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- AUC(0-24) for OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- Cmax for OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- Cmax for OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- Ctrough for OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- Ctrough for OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- Tmax for OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- Tmax for OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Part B- AUC(0-t) for Tauro-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- AUC(0-t) for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- AUC(0-24) for Tauro-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- AUC(0-24) for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- Cmax for Tauro-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- Cmax for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- Ctrough for Tauro-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- Ctrough for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- Tmax for Tauro-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- Tmax for Tauro-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Part B- AUC(0-t) for Glyco-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- AUC(0-t) for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- AUC(0-24) for Glyco-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- AUC(0-24) for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- Cmax for Glyco-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- Cmax for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- Ctrough for Glyco-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- Ctrough for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- Tmax for Glyco-OCA: OCA Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part B- Tmax for Glyco-OCA: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Part A- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. All Participants Population consisted of all participants who took at least 1 dose of study intervention.
Part B- Number of Participants With Any AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement.
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected Using Bazzet's Formula (QTcB), Corrected QT Interval Using Fredericia's Formula (QTcF): OCA Arm
Twelve lead electrocardiograms (ECGs) were obtained to measure PR interval, QRS duration, QT interval, QTcB and QTcF. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 5 minutes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcB, QTcF: OCA + Linerixibat Arm
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcB and QTcF. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 5 minutes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part B- Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcB, QTcF
Twelve lead ECGs were planned to be measured PR interval, QRS duration, QT interval, QTcB and QTcF. Twelve-lead ECGs were planned to be performed with the participant in a supine position after a rest of at least 5 minutes.
Part A- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): OCA Arm
SBP and DBP were measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in SBP and DBP: OCA + Linerixibat Arm
SBP and DBP were measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Pulse Rate: OCA Arm
Pulse rate was measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Pulse Rate: OCA + Linerixibat Arm
Pulse rate was measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Respiratory Rate: OCA Arm
Respiratory rate was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Respiratory Rate: OCA + Linerixibat Arm
Respiratory rate was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Body Temperature: OCA Arm
Body temperature was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Body Temperature: OCA + Linerixibat Arm
Body temperature was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part B- Change From Baseline in SBP and DBP
SBP and DBP were planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Part B- Change From Baseline in Pulse Rate
Pulse rate was planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Part B- Change From Baseline in Respiratory Rate
Respiratory rate was planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Part B- Change From Baseline in Body Temperature
Body temperature was planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and leukocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and leukocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Hemoglobin: OCA Arm
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Hemoglobin: OCA + Linerixibat Arm
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Hematocrit: OCA Arm
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Hematocrit: OCA + Linerixibat Arm
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin: OCA Arm
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin: OCA + Linerixibat Arm
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume: OCA Arm
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume: OCA + Linerixibat Arm
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes: OCA Arm
Blood samples were collected to analyze the hematology parameters: erythrocytes and reticulocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes: OCA + Linerixibat Arm
Blood samples were collected to analyze the hematology parameters: erythrocytes and reticulocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part B- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes
Blood samples were planned to be collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and leukocytes.
Part B- Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were planned to be collected to analyze the hematology parameter: hemoglobin.
Part B- Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were planned to be collected to analyze the hematology parameter: hematocrit.
Part B- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were planned to be collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Part B- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were planned to be collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Part B- Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes
Blood samples were planned to be collected to analyze the hematology parameters: erythrocytes and reticulocytes.
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA Arm
Blood samples were collected to analyze the chemistry parameters: glucose, calcium, potassium, sodium and urea. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA + Linerixibat Arm
Blood samples were collected to analyze the chemistry parameters: glucose, calcium, potassium, sodium and urea. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA Arm
Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA + Linerixibat Arm
Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST): OCA Arm
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Chemistry Parameters: ALT, ALP, AST: OCA + Linerixibat Arm
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Chemistry Parameter: Protein: OCA Arm
Blood samples were collected to analyze the chemistry parameter: protein. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part A- Change From Baseline in Chemistry Parameter: Protein: OCA + Linerixibat Arm
Blood samples were collected to analyze the chemistry parameter: protein. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Part B- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea
Blood samples were planned to be collected to analyze the chemistry parameters: glucose, calcium, potassium, sodium and urea.
Part B- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin
Blood samples were planned to be collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin.
Part B- Change From Baseline in Chemistry Parameters: ALT, ALP, AST
Blood samples were planned to be collected to analyze the chemistry parameters: ALT, ALP and AST.
Part B- Change From Baseline in Chemistry Parameter: Protein
Blood samples were planned to be collected to analyze the chemistry parameter: protein.
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Urine samples were collected from participants for urinalysis for measuring potential of hydrogen (pH) and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Abnormal urinalysis was sent for microscopic examination for cellular casts, erythrocytes, granular casts, hyaline casts, and leukocytes and were counted as cells per high-power field (cells/HPF). Baseline was considered as Day -1. Number of participants with worst case urinalysis result by microscopic examination have been presented.
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Urine samples were collected from participants for urinalysis for measuring pH and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Abnormal urinalysis was sent for microscopic examination for cellular casts, erythrocytes, granular casts, hyaline casts, and leukocytes and were counted as cells/HPF. Baseline was considered as Day -1. Number of participants with worst case urinalysis result by microscopic examination have been presented.
Part B- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Urine samples were planned to be collected from participants for urinalysis for measuring pH and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Abnormal urinalysis was planned to be sent for microscopic examination for cellular casts, erythrocytes, granular casts, hyaline casts, and leukocytes.
Part A- AUC(0-t) for Linerixibat: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Part A- Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) for Linerixibat: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Part A- Cmax for Linerixibat: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Part A- Tmax for Linerixibat: OCA + Linerixibat Arm
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Part B- AUC(0-t) for Linerixibat: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.
Part B- AUC(0-12) for Linerixibat: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.
Part B- Cmax for Linerixibat: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.
Part B- Tmax for Linerixibat: OCA + Linerixibat Arm
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.