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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-27

Study Completion Date

2022-10-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immune System Disorder Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1

Belumosudil + UGT1A1 victim drug administered in the fed state

Group Type EXPERIMENTAL

Belumosudil

Intervention Type DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

UGT1A1 victim drug

Intervention Type DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

Part 2

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

Group Type EXPERIMENTAL

Belumosudil

Intervention Type DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

P-gp victim drug

Intervention Type DRUG

Pharmaceutical form: Capsule; Route of administration: Oral

Part 3

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

Group Type EXPERIMENTAL

Belumosudil

Intervention Type DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

OATP1B1/BCRP victim drug

Intervention Type DRUG

Pharmaceutical form: Tablet; Route of administration: Oral

Interventions

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Belumosudil

Pharmaceutical form: Tablet; Route of administration: Oral

Intervention Type DRUG

UGT1A1 victim drug

Pharmaceutical form: Tablet; Route of administration: Oral

Intervention Type DRUG

P-gp victim drug

Pharmaceutical form: Capsule; Route of administration: Oral

Intervention Type DRUG

OATP1B1/BCRP victim drug

Pharmaceutical form: Tablet; Route of administration: Oral

Intervention Type DRUG

Other Intervention Names

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REZUROCK/KD025/SAR445761

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes