Clinical trial NCT06153758: Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4-Part
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Predose to 48 hours post danuglipron administration
measure: Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state
timeFrame: Predose to 48 hours post danuglipron administration
measure: 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
timeFrame: Predose to 48 hours post danuglipron administration
measure: 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
timeFrame: Predose to 48 hours post danuglipron administration
measure: Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state
timeFrame: Predose to 48 hours post danuglipron administration
measure: 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
timeFrame: Predose to 48 hours post danuglipron administration
Secondary outcomes:
measure: All Parts: Number of Participants reporting Treatment Emergent Adverse Events
timeFrame: From baseline up to 28-35 days post last dose taken
measure: All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
measure: All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
measure: All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
measure: 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
timeFrame: Predose to 48 hours post danuglipron administration
measure: All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state
timeFrame: Predose to 48 hours post danuglipron administration
measure: 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
timeFrame: Predose to 48 hours post danuglipron administration
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: