Healthy Participants, Healthy Subjects
Conditions
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.
Interventions
DRUGDanuglipron
Danuglipron oral tablets
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
4-Part
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| 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: 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 |
| 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 |
Countries
United States
Outcome results
None listed