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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1277-6732 | Registry Identifier | ICTRP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Belumosudil + UGT1A1 victim drug administered in the fed state |
|
| Part 2 | Experimental | Belumosudil + P-gp victim drug administered in the fed state |
|
| Part 3 | Experimental | Belumosudil + OATP1B1/BCRP victim drug administered in the fed state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belumosudil | Drug | Pharmaceutical form: Tablet; Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-last)- Parts 1,2, and 3 (victim drugs) | Area under the curve from time 0 to the time of last measurable concentration | 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 | Multiple timepoints up to approximately 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites) | Time of maximum observed concentration. | Multiple timepoints up to approximately 15 days |
| Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites) |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 8400001 | Miami | Florida | 33126 | United States |
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| Label | URL |
|---|---|
| INT17676 Plain Language Results Summary | View source |
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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
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| 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 |
|
Maximum observed concentration
| Multiple timepoints up to approximately 15 days |
| T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites) | Terminal elimination half-life | Multiple timepoints up to approximately 15 days |
| 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 |
| 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 |
| AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites) | 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) | 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. | Up to 30 days after the administration of last dose of study drug i.e., up to approximately 43 days |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000718240 | belumosudil |
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