Skip to main content
OpenTrials
Completed

NCT Number: NCT03880136

Food Effect Study of CTP-543 in Healthy Volunteers

Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Tempe, Arizona, 85283, United States

About this study

This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults between 18 and 55 years of age, inclusive
  • Body weight not less than 100 lbs and body mass index within the range of 18 to 32 kg/m2, inclusive, at screening

Exclusion criteria

  • History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions
  • PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit 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 at screening
  • Urinalysis positive for greater than trace blood, protein or glucose
  • History of drug or alcohol abuse within 6 months of screening
  • History of tobacco product use within 3 months prior to the study
  • Inability to comply with dietary restrictions during study participation
  • Blood donation or collection within 8 week prior to dosing
  • Positive pregnancy test

Treatment and study plan

CTP-543

Drug

Once daily dosing

Primary outcomes

  1. Measurement of CTP-543 in plasma under fed and fasted conditions

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.