Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants; Healthy Subjects

Treatments: Drug: Danuglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06153758

C3421074

Details and patient eligibility

About

The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older and overtly healthy
• Body mass Index (BMI) between 16-32 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion criteria

• Evidence or history of clinically significant medical conditions or laboratory abnormality
• Any condition possibly affecting drug absorption
• Known intolerance/hypersensitivity to a GLP-1 R agonist
• Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of the study.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Part A

Experimental group

Description:

Participants will receive a single oral dose of danuglipron on Day 1 of each period

Treatment:

Drug: Danuglipron

Part B

Experimental group

Description:

Participants will receive a single oral dose of danuglipron on Day 1 of each period

Treatment:

Drug: Danuglipron

Part C

Experimental group

Description:

Participants will receive a single oral dose of danuglipron on Day 1 of each period

Treatment:

Drug: Danuglipron

Part D

Experimental group

Description:

Participants will receive a single oral dose of danuglipron on Day 1 of each period

Treatment:

Drug: Danuglipron