A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants
Healthy

About this trial
This is an interventional treatment trial for Healthy focused on measuring Dabigatran etexitlate, Rosuvastatin, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, BCRP substrate, P-gp substrate, Anticoagulant, Antihyperlipidemic
Eligibility Criteria
Inclusion Criteria: Otherwise healthy female and male participants must be at least 18 years of age at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests) BMI: ≥25.0 kg/m2 at Screening Stable body weight, defined as <5 kg change (per participant report) for 90 days before Screening Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at Screening History of myocardial infarction, unstable angina, arterial revascularization, mechanical prosthetic heart valve, stroke, New York Association Functional Class II-IV heart failure, or transient ischemic attack within 6 months of Screening Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin) Personal or family history of MTC or MEN2, or study participants with suspected MTC per the investigator's judgment Acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis Symptomatic gallbladder disease Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders History of depressive disorder or history of other severe psychiatric disorders within the last 2 years from Screening Any lifetime history of a suicide attempt Known medical history of active liver disease, or prior known drug-induced liver injury History of HIV infection Recent history of bleeding, or risks of bleeding, or abnormal coagulation test (INR >1.3) result at Screening Use of prohibited medications Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study result Participants with clinical laboratory test abnormalities at Screening
Sites / Locations
- Qps-Mra, Llc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
Period 1
Period 2
Period 3
Period 4
Period 5
Period 6
Period 7
Period 8
Participants will receive dabagatrin etexilate (DE) as a single dose
Participants will receive rosuvastatin as a single dose
Participants will receive PF-07081532 daily titrated
Participants will receive PF-07081532 daily and DE as a single dose
Participants will receive PF-07081532 daily and rosuvastatin as a single dose
Participants will receive PF-07081532 daily titrated
Participants will receive PF-07081532 daily and DE as a single dose
Participants will receive PF-07081532 daily and rosuvastatin as a single dose