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Completed

NCT Number: NCT03830463

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTP-692

Drug

Single oral dose

Placebo

Drug

Single oral dose

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety

    Time frame: 48 hours

  2. Measurement of CTP-692 exposure in plasma under fasted conditions

    Time frame: 48 hours

  3. Measurement of CTP-692 exposure in plasma under fed conditions

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2019
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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