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

NCT06153758 | Completed Phase 1 FDA Drug

• 1 other identifier: C3421074
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants; Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (4)

Part A

EXPERIMENTAL

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

Drug: Danuglipron

Part B

EXPERIMENTAL

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

Drug: Danuglipron

Part C

EXPERIMENTAL

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

Drug: Danuglipron

Part D

EXPERIMENTAL

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

Drug: Danuglipron

Interventions

Danuglipron DRUG

Danuglipron oral tablets

Also known as: PF-06882961

Part A; Part B; Part C; Part D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Related Links

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

MeSH Terms

Interventions

danuglipron

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4-Part

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: November 27, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)