A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese
Phase 1
Not yet recruiting
- Conditions
- Obesity
- Registration Number
- NCT06567327
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Key Inclusion Criteria:<br><br> - 18 to < 65 years of age<br><br> - Body mass index (BMI) of =25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)<br><br>Key Exclusion Criteria:<br><br> - Evidence or history of any clinically significant medical conditions or laboratory<br> abnormality<br><br> - Any condition possibly affecting drug absorption<br><br> - Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivity<br> or contraindication to atorvastatin (Cohort 1 participants) or rosuvastatin (Cohort<br> 2 participants)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron;Steady-state maximum observed concentration (Cmax) for danuglipron;Steady-state time to reach maximum observed concentration (Tmax) for danuglipron;Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin;Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable);Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin;Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable)
- Secondary Outcome Measures
Name Time Method Number of participants reporting Treatment Emergent Adverse Events (TEAEs);Number of participants reporting clinically significant clinical laboratory abnormalities;Number of participants reporting clinically significant vital sign abnormalities;Change from baseline in body weight;Number of participants reporting clinically significant changes ECG abnormalities