A Phase 1, 4-Part, Open-Label, Randomized Study With A 5-Period, 4 Sequence, Crossover Design to Compare the Single Dose Pharmacokinetics Between Immediate and Modified Release Formulations of Danuglipron Administered Orally to Healthy Adult Participants

Registration

Registration

NCT06153758

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

33

Start

2023-11-27

Primary completion

2024-09-30

Lead sponsor

Pfizer

Conditions

Healthy Participants; Healthy Subjects

Interventions

DRUG:Danuglipron

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state [Predose to 48 hours post danuglipron administration]
• Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state [Predose to 48 hours post danuglipron administration]
• Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state [Predose to 48 hours post danuglipron administration]
• Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state [Predose to 48 hours post danuglipron administration]
• Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state [Predose to 48 hours post danuglipron administration]
• Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state [Predose to 48 hours post danuglipron administration]