Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers

Phase 1 Completed 73 enrolled Kadmon Corporation, LLC Quotient Sciences · collab

Non-randomizedSequentialOpen-labelBasic science

Summary

This is a single-center, 2-part, non-randomized, open-label study of the drug-drug interactions of belumosudil (KD025) with itraconazole, rifampicin, rabeprazole, and omeprazole in healthy male subjects.

Timeline

Start: 2018-04-09
Primary completion: 2019-02-08
Completion: 2019-02-08

Publications

Background Schueller O, Willson A, Singh N, Lohmer L, Alabanza A, Patel J. A Phase 1 Pharmacokinetic Drug Interaction Study of Belumosudil Coadministered With CYP3A4 Inhibitors and Inducers and Proton Pump Inhibitors. Clin Pharmacol Drug Dev. 2022 Jul;11(7):795-806. doi: 10.1002/cpdd.1082. Epub 2022 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belumosudil	Small molecule	200 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Omeprazole	Other / unclassified	20 mg	—
Subject	Rabeprazole	Small molecule	20 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral

Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers

Summary

Timeline

Publications

Drugs

Indications