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Completed

NCT Number: NCT05806567

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

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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Key information

Conditions

Immune System Disorder Healthy Volunteers Immune System Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number: 8400001

Miami, Florida, 33126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belumosudil

Drug

Pharmaceutical form: Tablet; Route of administration: Oral

Other names: REZUROCK/KD025/SAR445761

UGT1A1 victim drug

Drug

Pharmaceutical form: Tablet; Route of administration: Oral

P-gp victim drug

Drug

Pharmaceutical form: Capsule; Route of administration: Oral

OATP1B1/BCRP victim drug

Drug

Pharmaceutical form: Tablet; Route of administration: Oral

Primary outcomes

  1. AUC(0-last)- Parts 1,2, and 3 (victim drugs)

    Time frame: Multiple timepoints up to approximately 15 days

    Area under the curve from time 0 to the time of last measurable concentration

  2. AUC(0-inf)- Parts 1,2, and 3 (victim drugs

    Time frame: Multiple timepoints up to approximately 15 days

    Area under the curve from time 0 extrapolated to infinity

Secondary outcomes

  1. Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)

    Time frame: Multiple timepoints up to approximately 15 days

    Time of maximum observed concentration.

  2. Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)

    Time frame: Multiple timepoints up to approximately 15 days

    Maximum observed concentration

  3. T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)

    Time frame: Multiple timepoints up to approximately 15 days

    Terminal elimination half-life

  4. AUC(0-last)-Part 1 (victim metabolite)

    Time frame: Multiple timepoints up to approximately 10 days

  5. AUC(0-inf)- Part 1 (metabolite of victim drug)

    Time frame: Multiple timepoints up to approximately 10 days

  6. Tmax- Part 1(metabolite of victim drug)

    Time frame: Multiple timepoints up to approximately 10 days

  7. Cmax- Part 1 (metabolite of victim drug)

    Time frame: Multiple timepoints up to approximately 10 days

  8. T1/2- Part 1 (metabolite of victim drug)

    Time frame: Multiple timepoints up to approximately 10 days

  9. AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites)

    Time frame: Multiple timepoints up to approximately 15 days

  10. Area under the curve for the defined interval between doses (tau) [AUC(0 tau)] - Parts 1, 2, and 3

    Time frame: Multiple timepoints up to approximately 15 days

    Area under the curve for the defined interval between doses (tau)

  11. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 30 days after the administration of last dose of study drug i.e., up to approximately 43 days

    To provide additional safety and tolerability information for belumosudil by assessing: AEs, vital signs, ECGs, physical examinations and laboratory safety tests following administration of the three victim drugs alone and in combination with belumosudil.

Sponsors and collaborators

Lead sponsor

Kadmon, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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