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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1291-6021 | Other Identifier | ICTRP |
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The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.
Duration per participants is Day 1 up to 30 days after participant is treated with the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental | Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1 |
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| Dose level 2 | Experimental | Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1 |
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| Dose level 3 | Experimental | Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1 |
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| Dose level 4 | Experimental | Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1 |
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| Dose level 5 | Experimental | Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1 |
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| Dose level 6 | Experimental |
| 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. | Day 1 up to approximately 30 days after participant is treated with the last dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | Cmax is maximum plasma concentration determined directly from the concentration time profile | Predose and multiple timepoints up to 24 hours postdose on Day 1 |
| tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) |
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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 | Baltimore | Maryland | 21225 | 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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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000619755 | KD025 |
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Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1
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| Placebo | Drug | Pharmaceutical form: capsule; Route of administration: oral |
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tmax is observed time to reach peak plasma concentration |
| Predose and multiple timepoints up to 24 hours postdose on Day 1 |
| AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose | Predose and multiple timepoints up to 24 hours postdose on Day 1 |
| AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity | Predose and multiple timepoints up to 24 hours postdose on Day 1 |
| t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | t1/2 is terminal elimination half-life | Predose and multiple timepoints up to 24 hours postdose on Day 1 |