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

NCT05806567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Immune System Disorder
  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Kadmon, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-27
Primary Completion
2022-10-20
Completion
2022-10-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806567 on ClinicalTrials.gov