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

• Status: Not yet recruiting
• Trial end date: 2023-09-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants. This study also aims to collect data on safety and how tolerable the study medicine is.

The study is seeking for participants who are:

• Male or female who are 18 years of age or older.

• Healthy but are overweight or obese. Participants will receive dabigatran and rosuvastatin as single doses by mouth 3 times during the study. The amount of the study medicine PF-07081532 will be adjusted over time until any interactions are seen.

PF-07081532 is taken daily by mouth in 8 Study Periods while admitted into the study clinic over 53 days. Once discharged from the study clinic, participants will have a follow-up visit 7 to 10 days post last dose of study medicine. Then another follow-up via telephone contact, 28 to 35 days post last dose of study medicine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Dabigatran; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. 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)

2. BMI: ≥25.0 kg/m2 at Screening

3. Stable body weight, defined as <5 kg change (per participant report) for 90 days before Screening

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease

2. Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at Screening

3. 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

4. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin)

5. Personal or family history of MTC or MEN2, or study participants with suspected MTC per the investigator's judgment

6. Acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis

7. Symptomatic gallbladder disease

8. Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders

9. History of depressive disorder or history of other severe psychiatric disorders within the last 2 years from Screening

10. Any lifetime history of a suicide attempt

11. Known medical history of active liver disease, or prior known drug-induced liver injury

12. History of HIV infection

13. Recent history of bleeding, or risks of bleeding, or abnormal coagulation test (INR >1.3) result at Screening

14. Use of prohibited medications

15. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest

16. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study result

17. Participants with clinical laboratory test abnormalities at Screening