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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

CompletedPhase 1

Sponsor: Kadmon, a Sanofi Company

Conditions: Immune System Disorder, Healthy Volunteers

Interventions: Belumosudil, UGT1A1 victim drug, P-gp victim drug, OATP1B1/BCRP victim drug

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Miami, Florida, United States