A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects
- Conditions
- Immune System Disorder (Healthy Volunteer)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05918614
- Lead Sponsor
- Kadmon, a Sanofi Company
- Brief Summary
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.
- Detailed Description
Up to approximately 58 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Healthy participants between the ages of 18 and 55 years, inclusive.
- Female who is not of reproductive potential.
- 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.
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description KD025 Belumosudil mesylate 500 mg KD025 administered orally twice daily (BID) for 28 days Placebo Placebo Placebo administered orally BID for 28 days
- Primary Outcome Measures
Name Time Method Number of participants with adverse events and serious adverse events Up to approximately 58 days Number of participants with adverse events and serious adverse events
- Secondary Outcome Measures
Name Time Method Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 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
AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 AUC0 -τis area under the plasma concentration-time curve from predose (time 0) to end of dosing collection (30 hours)
AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 AUCinf, area under the concentration-time curve from predose (time 0) extrapolated to Infinity
Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 Cmax maximum plasma concentration determined directly from the concentration time profile
Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 tmax, observed time to reach peak plasma concentration
Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 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
t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 t1/2 terminal elimination half-life
Trial Locations
- Locations (1)
Investigational site
🇺🇸Buffalo, New York, United States