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

• Status: Completed
• Trial end date: 2022-10-28
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kadmon, a Sanofi Company
• Treatments: Belumosudil

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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.