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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period |
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| Part B | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period |
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| Part C | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period |
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| Part D | Experimental | Participants will receive a single oral dose of danuglipron on Day 1 of each period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danuglipron | Drug | Danuglipron oral tablets |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| C000731016 | danuglipron |
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4-Part
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| 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 |