Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers

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

This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CTP-692; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult males and females between 18 and 55 years of age, inclusive
• Body weight ≥ 55 kg and BMI 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single oral dose
Experimental: CTP-692	Drug: CTP-692; Single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety	48 hours
Measurement of CTP-692 exposure in plasma under fasted conditions	48 hours
Measurement of CTP-692 exposure in plasma under fed conditions	48 hours

Collaborators and Investigators

• Sponsor: Concert Pharmaceuticals
• Investigators: Study Director: Emily McIntyre, Concert Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 2, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CP692.1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No