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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study of PF-06882961.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. |
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| Cohort 2 | Experimental | Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. |
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| Cohort 3 (optional) | Experimental | Single Ascending Dose administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06882961 | Drug | Single Ascending Doses of PF-06882961 from 3mg to TBD mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Seriousness and Relationship to Treatment | Assessment by adverse event monitoring, 12 lead ECGs, cardiac telemetry, vital signs and clinical safety laboratory measurements. | First dose of study drug up to 28 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration |
| Maximum Observed Plasma Concentration (Cmax) |
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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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| C000731016 | danuglipron |
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Double-blind (sponsor open)
| Placebo | Other | Placebo Single Dose |
|
Maximum Observed Plasma Concentration (Cmax) |
| Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration |