A Study of JNJ-64251330 in Healthy Participants

Phase 1 Completed 36 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate: systemic and local gut (rectum and sigmoid colon) exposure to JNJ-64251330, local tissue Pharmacodynamics (PD) using gut (rectum and sigmoid colon) biopsies (Part 1) and the effect of food on the rate and extent of absorption of JNJ-64251330 from oral tablet dosed with or without food (Part 2).

Timeline

Start: 2020-09-02
Primary completion: 2020-12-29
Completion: 2020-12-29

Publications

Ma X, Borzillo G, Kothe MJC, Sanga M, Chu G, Greger JG, Deiteren A, Attiyeh E. A Phase I, Randomized, Multi-Dose Study to Evaluate the Enteric Selectivity and Safety of JAK Inhibitor, Lorpucitinib, in Healthy Participants. Clin Pharmacol Ther. 2024 May;115(5):1075-1084. doi: 10.1002/cpt.3170. Epub 2024 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-64251330	Small molecule	30 mg	Oral
Subject	JNJ-64251330	Small molecule	75 mg	Oral
Comparator	Tofacitinib	Small molecule	5 mg	Oral

Indications

No indication recorded.