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
1 other identifier
interventional
42
1 country
1
Brief Summary
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jan 2019
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2019
CompletedFirst Submitted
Initial submission to the registry
February 2, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2019
CompletedJune 13, 2019
June 1, 2019
2 months
February 2, 2019
June 12, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
CTP-692
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Study Officials
- STUDY DIRECTOR
Emily McIntyre
Concert Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2019
First Posted
February 5, 2019
Study Start
January 24, 2019
Primary Completion
March 28, 2019
Study Completion
March 28, 2019
Last Updated
June 13, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share