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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830463
• Other study ID #: CP692.1002
• Status: Completed
• Phase: Phase 1
• Start date: January 24, 2019
• Est. completion date: March 28, 2019

Study information

• Verified date: June 2019
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CTP-692
Single oral dose
• Placebo
Single oral dose

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Network, LLC	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety		48 hours
Primary	Measurement of CTP-692 exposure in plasma under fasted conditions		48 hours
Primary	Measurement of CTP-692 exposure in plasma under fed conditions		48 hours