A Randomized, Double-blind, Placebo-controlled, Dose Escalating Study to Examine the Safety, Tolerability and Pharmacokinetic Profile of Single Oral Doses of SLx-2119 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Belumosudil mesylate
- Conditions
- Immune System Disorder (Healthy Volunteer)
- Sponsor
- Kadmon, a Sanofi Company
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events and serious adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Dose level 2
Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1
Intervention: Belumosudil mesylate
Dose level 1
Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1
Intervention: Belumosudil mesylate
Dose level 1
Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1
Intervention: Placebo
Dose level 2
Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1
Intervention: Placebo
Dose level 3
Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1
Intervention: Belumosudil mesylate
Dose level 3
Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1
Intervention: Placebo
Dose level 4
Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1
Intervention: Belumosudil mesylate
Dose level 4
Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1
Intervention: Placebo
Dose level 5
Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1
Intervention: Belumosudil mesylate
Dose level 5
Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1
Intervention: Placebo
Dose level 6
Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1
Intervention: Belumosudil mesylate
Dose level 6
Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with adverse events and serious adverse events
Time Frame: 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 Outcomes
- tmax 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 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)(Predose and multiple timepoints up to 24 hours postdose on Day 1)
- AUCinf 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 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)(Predose and multiple timepoints up to 24 hours postdose on Day 1)
- Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)(Predose and multiple timepoints up to 24 hours postdose on Day 1)