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OpenTrials
Completed

NCT Number: NCT03778320

A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers

This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must give written and informed consent and any authorizations required by local law.
  • Must have a body mass index (BMI) between 18 kg/m2 and 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

D-Serine

Drug

Single oral dose

Primary outcomes

  1. The number of AEs in participants as a measure of safety and tolerability.

    Time frame: 7 days

  2. Measurement of CTP-692 exposure in plasma

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study title

A Randomized Single Dose Crossover Comparison of the Safety, Tolerability, and Pharmacokinetic Profile of CTP-692 Versus D-Serine

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Mar 15, 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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