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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002584-10 | EudraCT Number |
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This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral [14C]PF-06882961, 50 mg | Experimental | In this arm, a single oral dose of [14C]PF-06882961, 50 mg will be administered as a liquid formulation. |
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| Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug | Experimental | In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961, 100 ug, will be administered via intravenous infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]PF-06882961, 50 mg | Drug | A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1 | Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered. | Baseline through approximately hour 312 (day 14). Period 1 is 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite profiling/identification in plasma, urine, and feces | Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces. | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr) |
| Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands | |||
| PRA Health Sciences Utrecht |
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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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| PF-06882961, 50 mg and [14C]PF-06882961, 100 ug | Drug | A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion. |
|
Maximum Observed Plasma Radioactivity |
| 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961 | Time to Reach Maximum Observed Plasma Radioactivity | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 | Area under the plasma radioactivity-time profile from time 0 to time of the last quantifiable concentration (Clast) | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 | AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 | Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half. | 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 | Maximum Observed Plasma Concentration | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961 | Time to Reach Maximum Observed Plasma Concentration | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 | Area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast) | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 | AUCinf is Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961 | where MRT is the Mean Residence Time | 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr |
| Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961 | Systemic clearance, CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr |
| Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr |
| Absolute oral bioavailability (F) | Absolute oral bioavailability following administration of a single oral dose of PF-06882961 in reference to a single intravenous dose of [14C]PF-06882961 | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Fraction of dose absorbed following single oral administration of [14C]PF-06882961 | Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration in reference to intravenous administration | 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr |
| Number of participants with adverse events | adverse events | Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days |
| Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 | Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half. | 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr |
| Number of participants with safety laboratory test results above/below certain threshold | lab tests | baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days) |
| Number of participants with ECG measurements above/below certain threshold | ECGs | baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days) |
| Number of participants with vital measurements above/below certain threshold | vitals | baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days) |
| Utrecht |
| 3584 BL |
| Netherlands |