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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-9646 | Registry Identifier | ICTRP |
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The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple oral doses and regimens of KD025 in healthy male and post-menopausal female participants.
Up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 500 mg KD025 or placebo once daily (QD) for 7 days |
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| Cohort 2 | Experimental | 800 mg KD025 or placebo QD for 7 days |
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| Cohort 3 | Experimental | 500 mg KD025 or placebo twice daily (BID) for 7 days |
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| Cohort 4 | Experimental | 1000 mg KD025 or placebo QD for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belumosudil mesylate | Drug | Pharmaceutical form: capsule; Route of administration: oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events | Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs. | Up to approximately 37 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Cmax is maximum plasma concentration determined directly from the concentration time profile | Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7 |
| tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] |
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Inclusion Criteria:
Exclusion Criteria:
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 | Buffalo | New York | 14202 | United States |
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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|
| Placebo | Drug | Pharmaceutical form: capsule; Route of administration: oral |
|
tmax is observed time to reach peak plasma concentration |
| Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7 |
| AUC0-24 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose | Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7 |
| AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity | Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7 |
| Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Cmin is minimum or "trough" plasma concentration after its administration and just prior to the administration of a subsequent dose as determined from the concentration time profile | Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7 |
| t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | t1/2 is terminal elimination half-life | Predose and multiple timepoints up to 48 hours postdose on Days 1 and 7 |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000619755 | KD025 |
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