Immune System DisorderPhase 1NCT05806567
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
A Phase 1 study testing Belumosudil, UGT1A1 victim drug and P-gp victim drug in people with Immune System Disorder and Healthy Volunteers, run by Kadmon, a Sanofi Company at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immune System Disorder, Healthy Volunteers
- What is being tested?
- Belumosudil, UGT1A1 victim drug and P-gp victim drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2022to 28 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational Site Number: 8400001
Miami, Florida, 33126
About this study
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
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.
Read the 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.
- Conditions
- Immune System Disorder, Healthy Volunteers
- Being tested
- Belumosudil, UGT1A1 victim drug, P-gp victim drug, OATP1B1/BCRP victim drug
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
Also called REZUROCK/KD025/SAR445761
Pharmaceutical form: Tablet; Route of administration: Oral
UGT1A1 victim drugDrug
Pharmaceutical form: Tablet; Route of administration: Oral
P-gp victim drugDrug
Pharmaceutical form: Capsule; Route of administration: Oral
OATP1B1/BCRP victim drugDrug
Pharmaceutical form: Tablet; Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Belumosudil + UGT1A1 victim drug administered in the fed state Receives: Drug: Belumosudil; Drug: UGT1A1 victim drug |
| Part 2 | Experimental | Belumosudil + P-gp victim drug administered in the fed state Receives: Drug: Belumosudil; Drug: P-gp victim drug |
| Part 3 | Experimental | Belumosudil + OATP1B1/BCRP victim drug administered in the fed state Receives: Drug: Belumosudil; Drug: OATP1B1/BCRP victim drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-last)- Parts 1,2, and 3 (victim drugs)
Area under the curve from time 0 to the time of last measurable concentration
Measured: 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
Measured: Multiple timepoints up to approximately 15 days
Secondary outcomes (11)
Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Time of maximum observed concentration.
Measured: Multiple timepoints up to approximately 15 days
Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Maximum observed concentration
Measured: Multiple timepoints up to approximately 15 days
T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Terminal elimination half-life
Measured: Multiple timepoints up to approximately 15 days
AUC(0-last)-Part 1 (victim metabolite)
Measured: Multiple timepoints up to approximately 10 days
AUC(0-inf)- Part 1 (metabolite of victim drug)
Measured: Multiple timepoints up to approximately 10 days
Tmax- Part 1(metabolite of victim drug)
Measured: Multiple timepoints up to approximately 10 days
Cmax- Part 1 (metabolite of victim drug)
Measured: Multiple timepoints up to approximately 10 days
T1/2- Part 1 (metabolite of victim drug)
Measured: Multiple timepoints up to approximately 10 days
AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites)
Measured: 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)
Measured: 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.
Measured: Up to 30 days after the administration of last dose of study drug i.e., up to approximately 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start27 Jul 2022
- Primary completion20 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806567
- Sponsor's protocol ID
- INT17676
- Other IDs
- U1111-1277-6732
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05806567
- Acronym / sponsor ID
- INT17676
- Conditions
- Immune System Disorder, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kadmon, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Belumosudil, Drug: UGT1A1 victim drugBelumosudil + UGT1A1 victim drug administered in the fed state |
| Part 2 | Experimental | Drug: Belumosudil, Drug: P-gp victim drugBelumosudil + P-gp victim drug administered in the fed state |
| Part 3 | Experimental | Drug: Belumosudil, Drug: OATP1B1/BCRP victim drugBelumosudil + OATP1B1/BCRP victim drug administered in the fed state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelumosudilAlso: REZUROCK/KD025/SAR445761Pharmaceutical form: Tablet; Route of administration: Oral | Drug | Part 1, Part 2, Part 3 |
| UGT1A1 victim drugPharmaceutical form: Tablet; Route of administration: Oral | Drug | Part 1 |
| P-gp victim drugPharmaceutical form: Capsule; Route of administration: Oral | Drug | Part 2 |
| OATP1B1/BCRP victim drugPharmaceutical form: Tablet; Route of administration: Oral | Drug | Part 3 |
Primary outcome
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
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
11 secondary outcomes
Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Time frame: Multiple timepoints up to approximately 15 days
Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Time frame: Multiple timepoints up to approximately 15 days
T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
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
Time frame: Multiple timepoints up to approximately 15 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- INT17676 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
Related trials for Immune System Disorder
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belumosudil, UGT1A1 victim drug and P-gp victim drug in people with Immune System Disorder and Healthy Volunteers, run by Kadmon, a Sanofi Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-last)- Parts 1,2, and 3 (victim drugs) (time frame: Multiple timepoints up to approximately 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.