NCT05806567

A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects

A Three-part, Sequential, Non-randomized, Open-label Study Designed to Evaluate the Effect of Oral Belumosudil on UGT1A1, P-gp, BCRP and OATP1B1 Inhibition in the Fed State in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Kadmon, a Sanofi Company · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety and pharmacokinetics (PK) effect of belumosudil on the uridine diphosphate glucuronosyltransferase (UGT)1A1 (Part 1), P glycoprotein (P-gp) (Part 2) and breast cancer resistance protein (BCRP)/organic anion transporting polypeptide (OATP)1B1 (Part 3) inhibition in the fed state in healthy male subjects.

Detailed description

Part 1: The estimated time from screening until the follow-up phone call is approximately 6 weeks per subject. Part 2: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subject. Part 3: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects.

Conditions

• Immune System Disorder
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Belumosudil	Pharmaceutical form: Tablet; Route of administration: Oral
DRUG	UGT1A1 victim drug	Pharmaceutical form: Tablet; Route of administration: Oral
DRUG	P-gp victim drug	Pharmaceutical form: Capsule; Route of administration: Oral
DRUG	OATP1B1/BCRP victim drug	Pharmaceutical form: Tablet; Route of administration: Oral

Timeline

• Start date: 2022-07-27
• Primary completion: 2022-10-20
• Completion: 2022-10-28
• First posted: 2023-04-10
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study