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

Kadmon

Status and phase: Completed; Phase 1

Conditions: Immune System Disorder; Healthy Volunteers

Treatments: Drug: OATP1B1/BCRP victim drug; Drug: P-gp victim drug; Drug: UGT1A1 victim drug; Drug: Belumosudil

Study type: Interventional

Funder types: Industry

Identifiers

NCT05806567

INT17676

U1111-1277-6732 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Part 1: The estimated time from screening until the follow-up phone call is approximately 6 weeks per subject.

Part 2: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subject.

Part 3: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects.

Enrollment: 52 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

Part 1

Experimental group

Description:

Belumosudil + UGT1A1 victim drug administered in the fed state

Treatment:

Drug: Belumosudil

Drug: UGT1A1 victim drug

Part 2

Experimental group

Description:

Belumosudil + P-gp victim drug administered in the fed state

Treatment:

Drug: Belumosudil

Drug: P-gp victim drug

Part 3

Experimental group

Description:

Belumosudil + OATP1B1/BCRP victim drug administered in the fed state

Treatment:

Drug: Belumosudil

Drug: OATP1B1/BCRP victim drug