Back to resultsA Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
S-217622
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility Criteria
Inclusion Criteria:
- Body weight ≥50 kilograms (kg) and body mass index (BMI) within the range of ≥18.5 to <38.0 kilogram-meter squared (kg/m^2) at the Screening visit.
Participants With Hepatic Impairment
- A diagnosis of clinically stable hepatic disease for at least 1 month prior to the Screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography [CT] scan, magnetic resonance imaging [MRI], or ultrasonography).
Mild or moderate hepatic impairment based on the Child-Pugh classification score at the Screening visit to determine eligibility:
- Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
- Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)
- A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit.
Healthy Participants
- Matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and BMI (± 10%).
Exclusion Criteria:
- History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Participant with poor venous access.
Other inclusion and exclusion criteria may apply.
Sites / Locations
- Clinical Pharmacology of Miami, LLC
- Advanced Pharma CR, LLC
- Orlando Clinical Research Center, Inc.
- Nucleus Network
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
S-217622: Group A
S-217622: Group B
S-217622: Group C
Arm Description
Participants with mild hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.
Participants with moderate hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.
Participants with normal hepatic function will receive a single dose of S-217622 on Day 1, in a fasted state.
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of S-217622
Time to Maximum Plasma Concentration (Tmax) of S-217622
Area Under the Plasma Concentration-Time Curve (AUC) of S-217622
Terminal Elimination Half-Life (t1/2,z) of S-217622
Terminal Elimination Rate Constant (λz) of S-217622
Mean Residence Time (MRT) of S-217622
Apparent Total Clearance (CL/F) of S-217622
Apparent Volume of Distribution (Vz/F) of S-217622
Renal Clearance (CLR) of S-217622
Fraction of Dose Excreted in Urine (Feu) of S-217622
Fraction Unbound in Plasma (FU) of S-217622
Secondary Outcome Measures
Number of Participants with Treatment-Emergent Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05409911
Brief Title
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
Official Title
A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
April 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-217622: Group A
Arm Type
Experimental
Arm Description
Participants with mild hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.
Arm Title
S-217622: Group B
Arm Type
Experimental
Arm Description
Participants with moderate hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.
Arm Title
S-217622: Group C
Arm Type
Experimental
Arm Description
Participants with normal hepatic function will receive a single dose of S-217622 on Day 1, in a fasted state.
Intervention Type
Drug
Intervention Name(s)
S-217622
Intervention Description
Tablet for oral administration
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Time to Maximum Plasma Concentration (Tmax) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Area Under the Plasma Concentration-Time Curve (AUC) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Terminal Elimination Half-Life (t1/2,z) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Terminal Elimination Rate Constant (λz) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Mean Residence Time (MRT) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Apparent Total Clearance (CL/F) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Apparent Volume of Distribution (Vz/F) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Renal Clearance (CLR) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Fraction of Dose Excreted in Urine (Feu) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Title
Fraction Unbound in Plasma (FU) of S-217622
Time Frame
0 (predose) up to 336 hours postdose on Day 1 to Day 15
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment-Emergent Adverse Events
Time Frame
Up to Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body weight ≥50 kilograms (kg) and body mass index (BMI) within the range of ≥18.5 to <38.0 kilogram-meter squared (kg/m^2) at the Screening visit.
Participants With Hepatic Impairment
A diagnosis of clinically stable hepatic disease for at least 1 month prior to the Screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography [CT] scan, magnetic resonance imaging [MRI], or ultrasonography).
Mild or moderate hepatic impairment based on the Child-Pugh classification score at the Screening visit to determine eligibility:
Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)
A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit.
Healthy Participants
Matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and BMI (± 10%).
Exclusion Criteria:
History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function.
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Breast cancer within the past 10 years.
Participant with poor venous access.
Other inclusion and exclusion criteria may apply.
Facility Information:
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Orlando Clinical Research Center, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Nucleus Network
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
12. IPD Sharing Statement
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A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
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