A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects
- Conditions
- Immune System Disorder (Healthy Volunteer)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05918627
- Lead Sponsor
- Kadmon, a Sanofi Company
- Brief Summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.
- Detailed Description
Duration per participants is Day 1 up to 30 days after participant is treated with the last dose of study drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Healthy participants between the ages of 18 and 55 years, inclusive.
- Able to provide written informed consent prior to the performance of any study specific procedures.
- Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.
- Participants are excluded from the study if any of the following criteria apply:
- Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
- Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose level 1 Belumosudil mesylate Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1 Dose level 1 Placebo Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1 Dose level 2 Belumosudil mesylate Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1 Dose level 2 Placebo Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1 Dose level 3 Belumosudil mesylate Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1 Dose level 3 Placebo Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1 Dose level 4 Belumosudil mesylate Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1 Dose level 4 Placebo Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1 Dose level 5 Belumosudil mesylate Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1 Dose level 5 Placebo Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1 Dose level 6 Belumosudil mesylate Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1 Dose level 6 Placebo Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1
- Primary Outcome Measures
Name Time Method Number of participants with adverse events and serious adverse events Day 1 up to approximately 30 days after participant is treated with the last dose of study drug. Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.
- Secondary Outcome Measures
Name Time Method tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) Predose and multiple timepoints up to 24 hours postdose on Day 1 tmax is observed time to reach peak plasma concentration
AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) Predose and multiple timepoints up to 24 hours postdose on Day 1 AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose
t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) Predose and multiple timepoints up to 24 hours postdose on Day 1 t1/2 is terminal elimination half-life
AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) Predose and multiple timepoints up to 24 hours postdose on Day 1 AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity
Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) Predose and multiple timepoints up to 24 hours postdose on Day 1 Cmax is maximum plasma concentration determined directly from the concentration time profile
Trial Locations
- Locations (1)
Investigational site
🇺🇸Baltimore, Maryland, United States