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

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03830463
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 20.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: CTP-692; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 24, 2019
• Actual Primary Completion Date: Mar 28, 2019
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety [48 hours]

2. Measurement of CTP-692 exposure in plasma under fasted conditions [48 hours]

3. Measurement of CTP-692 exposure in plasma under fed conditions [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Collaborative Neuroscience Network, LLC	Long Beach	California	United States	90806

Sponsors and Collaborators

• Concert Pharmaceuticals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03830463
• Other Study ID Numbers: CP692.1002
• First Posted: Feb 5, 2019
• Last Update Posted: Jun 13, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 13, 2019