Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

Summary

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

Timeline

Start

2018-12-10

Primary completion

2019-02-21

Completion

2019-02-21

Publications

• 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.
• 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.

Drugs

Indications

No indication recorded.