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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05192369
• Other study ID #: CP543.1010
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2022
• Est. completion date: January 28, 2022

Study information

• Verified date: February 2022
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CTP-543
CTP-543 12 mg (1 x 12 mg tablet), dosed with water
• CTP-543
CTP-543 48 mg (4 x 12 mg tablet) dosed with water
• Moxifloxacin
Moxifloxacin (1 x 400 mg tablet) dosed with water
• Placebo
Placebo (1 tablet) dosed with water

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TQT Analysis	Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint	Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10