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

INT17676

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.

2022-07-27

2022-10-20

2022-10-28

Completed

Early phase I

52

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}

2023-07-14