Skip to main content
OpenTrials
Completed

NCT Number: NCT05192369

A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers

This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy, non-smoking, adult males or females aged 18-60
  • Body mass index of 18 to 32 mg/m2 at Screening
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or Electrocardiograms (ECGs)
  • If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
  • Understands the study procedures in the informed consent form and be willing and able to comply with the protocol

Exclusion criteria

  • History or presence of clinically significant medical or psychiatric condition or disease
  • History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
  • History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
  • History of prolonged QT syndrome or a Corrected QT-interval (QTc) with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females obtained at Screening visit or prior to the first dosing
  • Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
  • Positive results at Screening for human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus
  • A positive test or history of incompletely treated or untreated tuberculosis

Treatment and study plan

CTP-543

Drug

CTP-543 12 mg (1 x 12 mg tablet), dosed with water

moxifloxacin

Drug

Moxifloxacin (1 x 400 mg tablet) dosed with water

Placebo

Drug

Placebo (1 tablet) dosed with water

Primary outcomes

  1. TQT Analysis

    Time frame: Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10

    Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study title

A Four-Arm, Randomized, Crossover, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Doses of CTP-543 on the QT/QTc Intervals in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2022
Registry last updated
Mar 4, 2022

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.