A Two-Part Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Multiple Dose Pharmacokinetics of Danuglipron Following Oral Administration and The Effects of Steady-State Danuglipron on the Pharmacokinetics of Single Oral Dose of Atorvastatin and Rosuvastatin in Otherwise Healthy Adult Participants With Overweight or Obesity

Registration

Registration

NCT06567327

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

82

Start

2024-08-28

Primary completion

2025-03-16

Lead sponsor

Pfizer

Conditions

Obesity

Interventions

DRUG:Danuglipron; DRUG:Atorvastatin; DRUG:Rosuvastatin

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

REGISTRY:NCT06567327

Registered primary outcomes

• Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron [Predose to 24 hours post danuglipron administration]
• Steady-state maximum observed concentration (Cmax) for danuglipron [Predose to 24 hours post danuglipron administration]
• Steady-state time to reach maximum observed concentration (Tmax) for danuglipron [Predose to 24 hours post danuglipron administration]
• Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin [Predose to 72 hours post atorvastatin administration]
• 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) [Predose to 72 hours post atorvastatin administration]
• Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin [Predose to 96 hours post rosuvastatin administration]
• 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) [Predose to 96 hours post rosuvastatin administration]