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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-9655 | Registry Identifier | ICTRP |
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The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.
Up to approximately 58 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 |
|---|---|---|---|
| KD025 | Experimental | 500 mg KD025 administered orally twice daily (BID) for 28 days |
|
| Placebo | Placebo Comparator | Placebo administered orally BID for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belumosudil mesylate | Drug | Pharmaceutical form: capsule; Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and serious adverse events | Number of participants with adverse events and serious adverse events | Up to approximately 58 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Cmax maximum plasma concentration determined directly from the concentration time profile | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 |
| 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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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000619755 | KD025 |
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| Placebo | Drug | Pharmaceutical form: capsule; Route of administration: oral |
|
tmax, observed time to reach peak plasma concentration |
| Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 |
| Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Cmin, Minimum or "trough" plasma concentration after its administration and just prior to the administration of a subsequent dose as determined from the concentration time cprofile | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 |
| AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | AUC0 -τis area under the plasma concentration-time curve from predose (time 0) to end of dosing collection (30 hours) | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 |
| AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | AUCinf, area under the concentration-time curve from predose (time 0) extrapolated to Infinity | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 |
| Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Accumulation ratio, determined as the ratio of Day 28 AUC divided by Day 1 AUC and as the ratio of Day 28 Cmax divided by Day 1 Cmax | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 |
| t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | t1/2 terminal elimination half-life | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 |