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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002403-34 | EudraCT Number |
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An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-period, fixed sequence | Experimental | fixed sequence with 2 treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral PF-06700841 containing 14C microtracer | Drug | Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period |
|
| Measure | Description | Time Frame |
|---|---|---|
| mass balance_urine | cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered | hour 0 up to 312 hours post dose |
| mass balance_feces | cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered | hour 0 up to 312 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| metabolite identification_plasma | metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| plasma Cmax for total 14C radioactivity |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39111823 | Derived | Bauman JN, Doran AC, Gualtieri GM, Hee B, Strelevitz T, Cerny MA, Banfield C, Plotka A, Wang X, Purohit VS, Dowty ME. The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Ritlecitinib, a Janus Kinase 3 and Tyrosine-Protein Kinase Family Inhibitor, in Humans. Drug Metab Dispos. 2024 Sep 16;52(10):1124-1136. doi: 10.1124/dmd.124.001843. | |
| 37183779 |
| 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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| Oral unlabeled PF-06700841 | Drug | 60 mg unlabeled PF-06700841 oral dose in 2nd period |
|
| IV 14C-labeled PF-06700841 | Drug | 30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period |
|
maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
| hour 0 up to 312 hours post dose |
| plasma Tmax for total 14C radioactivity | time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| plasma AUClast for total 14C radioactivity | area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| plasma AUCinf for total 14C radioactivity | area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| Oral clearance for total 14C radioactivity | oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| plasma half-life for total 14C radioactivity | half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| volume of distribution for total 14C radioactivity | apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| plasma Cmax for PF-06700841 | maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma Tmax for PF-06700841 | time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma AUClast for PF-06700841 | area under curve of PF-06700841 in plasma from time 0 to tlast following a single oral dose of 14C-labeled or unlabeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma AUCinf for PF-06700841 | area under curve of PF-06700841 in plasma from time 0 to infinite following a single oral dose of 14C-labeled or unlabeled PF-06700841 | hour 0 up to 96 hours post dose |
| Oral clearance for PF-06700841 | oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma half-life for PF-06700841 | half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841 | hour 0 up to 96 hours post dose |
| volume of distribution for PF-06700841 | apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma Cmax for 14C-labeled PF-06700841 | maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma Tmax for 14C-labeled PF-06700841 | time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma AUClast for 14C-labeled PF-06700841 | area under curve of 14C-labeled PF-06700841 in plasma from time 0 to tlast following a single iv dose of 14C-labeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma AUCinf for 14C-labeled PF-06700841 | area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841 | hour 0 up to 96 hours post dose |
| clearance for 14C-labeled PF-06700841 | clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841 | hour 0 up to 96 hours post dose |
| plasma half-life for 14C-labeled PF-06700841 | half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841 | hour 0 up to 96 hours post dose |
| volume of distribution for 14C-labeled PF-06700841 | volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841 | hour 0 up to 96 hours post dose |
| unchanged PF-06700841 recovered in urine | percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841 | hour 0 up to 96 hours post dose |
| renal clearance of PF-06700841 | renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841) | hour 0 up to 96 hours post dose |
| Bioavailability of oral PF-06700841 | Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841 | hour 0 up to 96 hours post dose |
| Fraction absorbed of oral PF-06700841 | Fraction absorbed in gut (Fa) following oral dose of PF-06700841 | hour 0 up to 144 hours post dose |
| metabolite identification_urine | metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| metabolite identification_feces | metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841 | hour 0 up to 312 hours post dose |
| Utrecht |
| 3584 BL |
| Netherlands |
| Qiu R, Sharma R, Wei H, Kirkovsky L, Zhou Y, Martin DDA, Banfield C, Dowty ME. A phase 1 study to investigate the absorption, distribution, metabolism and excretion of brepocitinib in healthy males using a 14 C-microdose approach. Br J Clin Pharmacol. 2023 Oct;89(10):3056-3066. doi: 10.1111/bcp.15786. Epub 2023 Jun 20. |