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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Healthy Participants
• Intervention / Treatment: Drug: Danuglipron

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; Participants will receive a single oral dose of danuglipron on Day 1 of each period	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961
Experimental: Part B; Participants will receive a single oral dose of danuglipron on Day 1 of each period	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961
Experimental: Part C; Participants will receive a single oral dose of danuglipron on Day 1 of each period	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961
Experimental: Part D; Participants will receive a single oral dose of danuglipron on Day 1 of each period	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
All Parts: Number of Participants reporting Treatment Emergent Adverse Events	From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities	From baseline up to 28-35 days post last dose taken
All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities	From baseline up to 28-35 days post last dose taken
All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities	From baseline up to 28-35 days post last dose taken
All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state	Predose to 48 hours post danuglipron administration
All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state	Predose to 48 hours post danuglipron administration
All Parts: 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 fed state	Predose to 48 hours post danuglipron administration

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: C3421074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No