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Completed

NCT Number: NCT06153758

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

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.

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Key information

Conditions

Healthy Participants Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Danuglipron

Drug

Danuglipron oral tablets

Other names: PF-06882961

Primary outcomes

  1. 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

    Time frame: Predose to 48 hours post danuglipron administration

  2. Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state

    Time frame: Predose to 48 hours post danuglipron administration

  3. 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

    Time frame: Predose to 48 hours post danuglipron administration

  4. 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

    Time frame: Predose to 48 hours post danuglipron administration

  5. Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state

    Time frame: Predose to 48 hours post danuglipron administration

  6. 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

    Time frame: Predose to 48 hours post danuglipron administration

Secondary outcomes

  1. All Parts: Number of Participants reporting Treatment Emergent Adverse Events

    Time frame: From baseline up to 28-35 days post last dose taken

  2. All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities

    Time frame: From baseline up to 28-35 days post last dose taken

  3. All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities

    Time frame: From baseline up to 28-35 days post last dose taken

  4. All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities

    Time frame: From baseline up to 28-35 days post last dose taken

  5. 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

    Time frame: Predose to 48 hours post danuglipron administration

  6. All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state

    Time frame: Predose to 48 hours post danuglipron administration

  7. 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

    Time frame: Predose to 48 hours post danuglipron administration

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2023
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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