A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-28

Study Completion Date

2014-06-07

Brief Summary

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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.

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Detailed Description

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Up to approximately 58 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Conditions

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Immune System Disorder (Healthy Volunteer)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KD025

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

Group Type EXPERIMENTAL

Belumosudil mesylate

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Placebo

Placebo administered orally BID for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pharmaceutical form: capsule; Route of administration: oral

Interventions

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Belumosudil mesylate

Pharmaceutical form: capsule; Route of administration: oral

Intervention Type DRUG

Placebo

Pharmaceutical form: capsule; Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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KD025 SAR445761

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes