drugset / Trial / NCT02310750
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
RandomizedParallel-groupTriple-blind
Summary
The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms).
Timeline
- Start
- 2014-11
- Primary completion
- 2016-01
- Completion
- 2016-02
Publications
- Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
- Page KM, Suarez-Farinas M, Suprun M, Zhang W, Garcet S, Fuentes-Duculan J, Li X, Scaramozza M, Kieras E, Banfield C, Clark JD, Fensome A, Krueger JG, Peeva E. Molecular and Cellular Responses to the TYK2/JAK1 Inhibitor PF-06700841 Reveal Reduction of Skin Inflammation in Plaque Psoriasis. J Invest Dermatol. 2020 Aug;140(8):1546-1555.e4. doi: 10.1016/j.jid.2019.11.027. Epub 2020 Jan 21.
- Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brepocitinib | Small molecule | 1 mg | Oral |
| Subject | Brepocitinib | Small molecule | 3 mg | Oral |
| Subject | Brepocitinib | Small molecule | 10 mg | Oral |
| Subject | Brepocitinib | Small molecule | 30 mg | Oral |
| Subject | Brepocitinib | Small molecule | 50 mg | Oral |
| Subject | Brepocitinib | Small molecule | 100 mg | Oral |
| Subject | Brepocitinib | Small molecule | 175 mg | Oral |
| Subject | Brepocitinib | Small molecule | 200 mg | Oral |