A Phase 1, Placebo-Controlled, Double-Blind Study to Examine the Safety, Tolerability, and Pharmacokinetics of 500 mg KD025 Administered Twice Daily in Healthy Male and Post-Menopausal Female Subjects

Kadmon, a Sanofi Company1 site in 1 country8 target enrollmentMarch 28, 2014

ConditionsImmune System Disorder (Healthy Volunteer)

InterventionsBelumosudil mesylate Placebo

DrugsBelumosudil mesylate Placebo

Overview

Phase: Phase 1
Intervention: Belumosudil mesylate
Conditions: Immune System Disorder (Healthy Volunteer)
Sponsor: Kadmon, a Sanofi Company
Enrollment: 8
Locations: 1
Primary Endpoint: Number of participants with adverse events and serious adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 28, 2014

End Date

June 7, 2014

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kadmon, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

KD025

500 mg KD025 administered orally twice daily (BID) for 28 days

Intervention: Belumosudil mesylate

Placebo

Placebo administered orally BID for 28 days

Intervention: Placebo

Outcomes

Primary Outcomes

Number of participants with adverse events and serious adverse events

Time Frame: Up to approximately 58 days

Number of participants with adverse events and serious adverse events

Secondary Outcomes

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)
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)
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)
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)
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)
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)
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)