A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron in Healthy Adult Participants

Registration

Registration

NCT06541678

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

16

Start

2024-12-23

Primary completion

2025-03-10

Lead sponsor

Pfizer

Conditions

Healthy

Interventions

DRUG:Danuglipron; DRUG:Cyclosporine; DRUG:Itraconazole

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

REGISTRY:2024-513863-21-00

Registered primary outcomes

• AUCinf (if data permits otherwise AUClast): to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants. [0 to 72 hour postdose]
• Cmax: to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants. [0 to 72 hour postdose]
• AUCinf (if data permits otherwise AUClast): to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants. [0 to 72 hour postdose]
• Cmax: to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants. [0 to 72 hour postdose]