A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers

Concert Pharmaceuticals1 site in 1 country30 target enrollmentApril 10, 2019

ConditionsHealthy

InterventionsCTP-692

DrugsCTP-692

Overview

Phase: Phase 1
Intervention: CTP-692
Conditions: Healthy
Sponsor: Concert Pharmaceuticals
Enrollment: 30
Locations: 1
Primary Endpoint: Measurement of CTP-692 exposure in plasma
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.

Registry

clinicaltrials.gov

Start Date

April 10, 2019

End Date

May 16, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Concert Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult males and females between 18 and 55 years of age, inclusive
•Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive

Exclusion Criteria

•Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
•Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
•History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
•Positive drug or alcohol test at screening or prior to the first dose of study drug