A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
- Conditions
- Immune System Disorder (Healthy Volunteers)
- Interventions
- Registration Number
- NCT05806567
- Lead Sponsor
- Kadmon, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 52
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 Belumosudil Belumosudil + P-gp victim drug administered in the fed state Part 2 P-gp victim drug Belumosudil + P-gp victim drug administered in the fed state Part 3 Belumosudil Belumosudil + OATP1B1/BCRP victim drug administered in the fed state Part 1 UGT1A1 victim drug Belumosudil + UGT1A1 victim drug administered in the fed state Part 3 OATP1B1/BCRP victim drug Belumosudil + OATP1B1/BCRP victim drug administered in the fed state Part 1 Belumosudil Belumosudil + UGT1A1 victim drug administered in the fed state
- Primary Outcome Measures
Name Time Method AUC(0-inf)- Parts 1,2, and 3 (victim drugs Multiple timepoints up to approximately 15 days Area under the curve from time 0 extrapolated to infinity
AUC(0-last)- Parts 1,2, and 3 (victim drugs) Multiple timepoints up to approximately 15 days Area under the curve from time 0 to the time of last measurable concentration
- Secondary Outcome Measures
Name Time Method AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites) Multiple timepoints up to approximately 15 days Cmax- Part 1 (metabolite of victim drug) Multiple timepoints up to approximately 10 days T1/2- Part 1 (metabolite of victim drug) Multiple timepoints up to approximately 10 days T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites) Multiple timepoints up to approximately 15 days Terminal elimination half-life
AUC(0-last)-Part 1 (victim metabolite) Multiple timepoints up to approximately 10 days AUC(0-inf)- Part 1 (metabolite of victim drug) Multiple timepoints up to approximately 10 days Tmax- Part 1(metabolite of victim drug) Multiple timepoints up to approximately 10 days Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites) Multiple timepoints up to approximately 15 days Time of maximum observed concentration.
Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites) Multiple timepoints up to approximately 15 days Maximum observed concentration
Area under the curve for the defined interval between doses (tau) [AUC(0 tau)] - Parts 1, 2, and 3 Multiple timepoints up to approximately 15 days Area under the curve for the defined interval between doses (tau)
Number of participants with adverse events (AEs) and serious adverse events (SAEs) 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.
Trial Locations
- Locations (1)
Investigational Site Number: 8400001
🇺🇸Miami, Florida, United States