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

Completed · Phase 1

Conditions studied: Immune System Disorder, Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05806567

Run by

Kadmon, a Sanofi Company

People needed

52

Starts

2022-07-27

Expected to finish

2022-10-28

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male participants aged 18 to 55 years old
• Must agree to use an adequate method of contraception
• Must be able to understand and provide a written informed consent

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
• Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
• Failure to satisfy the investigator of fitness to participate for any other reason.
• The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Where it is running

• Investigational Site Number: 8400001 — Miami, Florida, United States

Full record on ClinicalTrials.gov

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