Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003551-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate the absorption, distribution, metabolism and excretion (ADME) of 14C PF-06651600 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-06651600 in humans.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period A | Experimental | Single oral dose of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF 06651600). |
|
| Period B | Experimental | Single oral dose of 200 milligrams (mg) unlabeled PF-06651600 followed at time of peak plasma concentration (Tmax) by an Intravenous (IV) dose of 60 micrograms.14C -PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF-06651600). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-PF-06651600 | Drug | Oral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance: Cumulative recovery (%) of radioactivity in urine | Cumulative recovery (%) of radioactivity in urine. | from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24 |
| Mass Balance: Cumulative recovery (%) of radioactivity in feces | Cumulative recovery (%) of radioactivity in feces | from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount (% of the administered dose) of major metabolites of PF-06651600 in plasma | Hour 0 up to 312 hours post-dose. | |
| Amount (% of the administered dose) of major metabolites of PF-06651600 in urine | Hour 0 up to 312 hours post-dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Only Male participants will be enrolled.
Not provided
Not provided
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 14C-PF-06651600 IV | Drug | IV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity |
|
| PF-06651600 | Drug | Oral solution 200mg |
|
| Amount (% of the administered dose) of major metabolites of PF-06651600 in feces | Hour 0 up to 312 hours post-dose. |
| Cmax | Maximum plasma concentration | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| AUClast | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast) | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| AUCinf | Area under the plasma concentration time profile from time 0 to infinity | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| Tmax | Time for Cmax | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| t1/2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| CL (IV) | 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). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| CL/F (oral) | 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). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| Vss | Steady state volume of distribution following IV infusion | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| Vz/F | Apparent volume of distribution following oral administration | Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose |
| Total 14C_Urine_PO | Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of 14C PF 06651600 microtracer dose | Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose |
| Total 14C_Urine_IV | Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following IV administration of 14C PF 06651600 microtracer dose | Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose |
| AE | Number of subjects and number of AEs which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug. | Baseline (Day 0) up to 90 days after last dose of study medication |
| Number of participants with clinically significant changes to the physical examination | clinically significant changes to the physical examination | Baseline (Day 0) up to Day 24 |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) obtained from each participant. Clinical significance of vital signs was determined at the investigator's discretion. | Baseline (Day 0) up to Day 24 |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Laboratory parameters include: hematological and chemical parameters | Baseline (Day 0) up to Day 24 |
| Utrecht |
| 3584 BL |
| Netherlands |
| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
Not provided
Not provided
Not provided