Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03880253
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 25.4

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers
• Actual Study Start Date: Apr 10, 2019
• Actual Primary Completion Date: May 16, 2019
• Actual Study Completion Date: May 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTP-692 Low Dose or Matching Placebo Once daily dosing	Drug: CTP-692; Placebo or CTP-692
Experimental: CTP-692 Mid Dose or Matching Placebo Once daily dosing	Drug: CTP-692; Placebo or CTP-692
Experimental: CTP-692 High Dose or Matching Placebo Once daily dosing	Drug: CTP-692; Placebo or CTP-692

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events as a measure of safety [Assessments done Day 1 - 9]

2. Measurement of CTP-692 exposure in plasma [Assessments done Day 1 - 9]

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 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

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

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03880253
• Other Study ID Numbers: CP692.1003
• First Posted: Mar 19, 2019
• Last Update Posted: Jun 13, 2019
• Last Verified: Jun 1, 2019

• 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