Clinical trial NCT05806567: A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Disorder (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-04-10
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: AUC(0-last)- Parts 1,2, and 3 (victim drugs)
timeFrame: Multiple timepoints up to approximately 15 days
measure: AUC(0-inf)- Parts 1,2, and 3 (victim drugs
timeFrame: Multiple timepoints up to approximately 15 days
Secondary outcomes:
measure: Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
timeFrame: Multiple timepoints up to approximately 15 days
measure: Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
timeFrame: Multiple timepoints up to approximately 15 days
measure: T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
timeFrame: Multiple timepoints up to approximately 15 days
measure: AUC(0-last)-Part 1 (victim metabolite)
timeFrame: Multiple timepoints up to approximately 10 days
measure: AUC(0-inf)- Part 1 (metabolite of victim drug)
timeFrame: Multiple timepoints up to approximately 10 days
measure: Tmax- Part 1(metabolite of victim drug)
timeFrame: Multiple timepoints up to approximately 10 days
measure: Cmax- Part 1 (metabolite of victim drug)
timeFrame: Multiple timepoints up to approximately 10 days
measure: T1/2- Part 1 (metabolite of victim drug)
timeFrame: Multiple timepoints up to approximately 10 days
measure: AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites)
timeFrame: Multiple timepoints up to approximately 15 days
measure: Area under the curve for the defined interval between doses (tau) [AUC(0 tau)] - Parts 1, 2, and 3
timeFrame: Multiple timepoints up to approximately 15 days
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 30 days after the administration of last dose of study drug i.e., up to approximately 43 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigational Site Number: 8400001
state: Florida
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: