A Phase 1 interventional study of Belumosudil and UGT1A1 victim drug in Immune System Disorder and Healthy Volunteers, sponsored by Kadmon, a Sanofi Company. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Kadmon, a Sanofi Company (part of Sanofi) · Phase 1, Interventional, and Basic science
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
427 studies on the registry are indexed under Immune System Diseases; 86 are open to participants now.
This study's enrollment of 52 is below the median of 66 across 317 interventional studies indexed under Immune System Diseases.
Browse Immune System Diseases studies →Kadmon, a Sanofi Company is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
First submitted after Kadmon Corporation, LLC became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Belumosudil + UGT1A1 victim drug administered in the fed state
Drug: Belumosudil · Drug: UGT1A1 victim drug
Belumosudil + P-gp victim drug administered in the fed state
Drug: Belumosudil · Drug: P-gp victim drug
Belumosudil + OATP1B1/BCRP victim drug administered in the fed state
Drug: Belumosudil · Drug: OATP1B1/BCRP victim drug
Pharmaceutical form: Tablet; Route of administration: Oral
Also known as: REZUROCK/KD025/SAR445761
Pharmaceutical form: Tablet; Route of administration: Oral
Pharmaceutical form: Capsule; Route of administration: Oral
Pharmaceutical form: Tablet; Route of administration: Oral
AUC(0-last)- Parts 1,2, and 3 (victim drugs)
Area under the curve from time 0 to the time of last measurable concentration
Time frame: Multiple timepoints up to approximately 15 days
AUC(0-inf)- Parts 1,2, and 3 (victim drugs
Area under the curve from time 0 extrapolated to infinity
Time frame: Multiple timepoints up to approximately 15 days
Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Time of maximum observed concentration.
Time frame: Multiple timepoints up to approximately 15 days
Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Maximum observed concentration
Time frame: Multiple timepoints up to approximately 15 days
T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Terminal elimination half-life
Time frame: Multiple timepoints up to approximately 15 days
AUC(0-last)-Part 1 (victim metabolite)
Time frame: Multiple timepoints up to approximately 10 days
AUC(0-inf)- Part 1 (metabolite of victim drug)
Time frame: Multiple timepoints up to approximately 10 days
Tmax- Part 1(metabolite of victim drug)
Time frame: Multiple timepoints up to approximately 10 days
Cmax- Part 1 (metabolite of victim drug)
Time frame: Multiple timepoints up to approximately 10 days
T1/2- Part 1 (metabolite of victim drug)
Time frame: Multiple timepoints up to approximately 10 days
AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites)
Time frame: Multiple timepoints up to approximately 15 days
Area under the curve for the defined interval between doses (tau) [AUC(0 tau)] - Parts 1, 2, and 3
Area under the curve for the defined interval between doses (tau)
Time frame: Multiple timepoints up to approximately 15 days
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
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.
Time frame: Up to 30 days after the administration of last dose of study drug i.e., up to approximately 43 days
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Jul 2022 to primary completion in Oct 2022, 2 months.
Of 25 industry-sponsored phase 1 interventional studies under Immune System Diseases, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's 2 months is below that.
Counting every sponsor, half of 39 studies reached it within 29 months; a quarter within 5 and three quarters within 69.
Immune System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.