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This open label study will evaluate the pharmacokinetics (PK) following single oral doses of different formulations of PF-06882961, including controlled release (CR) tablets at 2 release rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06882961 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06882961 Immediate Release Tablet | Drug | Immediate Release Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for PF-06882961 | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period | |
| Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961 | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period | |
| Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast) | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period | |
| Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period |
| Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24) | 24 hours post dose in each period | |
| Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period |
| Apparent clearance (CL/F) for PF-06882961, as data permit | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-emergent adverse events (AEs) | Assessment by adverse event monitoring, 12 lead ECGs, vital signs and clinical safety laboratory measurements. | Baseline to at least 28 days after last dose |
| AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state |
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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 |
|---|---|---|---|---|---|---|
| Pfizer 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 |
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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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| PF-06882961 Controlled Release Tablet (long) |
| Drug |
Controlled Release tablet (long) |
|
| PF-06882961 Controlled Release Tablet (short) | Drug | Controlled Release tablet (short) |
|
| PF-06882961 Immediate Release Solution | Drug | PF-06882961 Immediate Release solution |
|
| 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period |
| Peak-to-trough (PTR) ratio for PF-06882961 | Calculated as ratio of Cmax to C24 | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period |
| 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose |
| AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose |
| Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose |
| AUClast for PF-06882961 for CR tablet (long) in fed and fasted states | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose |
| AUCinf for PF-06882961 for CR tablet (long) in fed and fasted states, as data permit | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose |
| Cmax for PF-06882961 for CR tablet (long) in fed and fasted states | 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose |
| ID | Term |
|---|---|
| C000731016 | danuglipron |
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