drugset / Trial / NCT01835197
First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects
RandomizedParallel-groupDouble-blindBasic science
Summary
This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a Janus kinase1 (JAK1) inhibitor, in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Western and Japanese subjects.
Timeline
- Start
- 2013-05
- Primary completion
- 2014-06
- Completion
- 2014-06
Publications
- Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
- Peeva E, Hodge MR, Kieras E, Vazquez ML, Goteti K, Tarabar SG, Alvey CW, Banfield C. Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: A phase 1, randomized, placebo-controlled, dose-escalation study. Br J Clin Pharmacol. 2018 Aug;84(8):1776-1788. doi: 10.1111/bcp.13612. Epub 2018 May 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abrocitinib | Small molecule | 3 mg | — |
| Subject | Abrocitinib | Small molecule | 10 mg | — |
| Subject | Abrocitinib | Small molecule | 30 mg | — |
| Subject | Abrocitinib | Small molecule | 100 mg | — |
| Subject | Abrocitinib | Small molecule | 200 mg | — |
| Subject | Abrocitinib | Small molecule | 400 mg | — |
| Subject | Abrocitinib | Small molecule | 800 mg | — |
Indications
No indication recorded.