A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults

Phase 1 Completed 12 enrolled Pfizer

RandomizedCrossoverOpen-labelBasic science

Summary

A phase I, single dose study to test two forms of pediatric ritlecitinib compared to adult ritlecitinib in healthy adults aged 18-55 years old. Approximately 12 adults will participate for approximately 2.5 months.

Timeline

Start: 2021-09-10
Primary completion: 2021-11-19
Completion: 2021-11-19

Publications

Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ritlecitinib	Small molecule	30 mg	Oral

Indications

No indication recorded.