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

NCT05192369 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Keywords

CTP-543

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Treatment A: Therapeutic Dose

EXPERIMENTAL

Single oral dose of 12mg CTP-543

Drug: CTP-543

Treatment B: Supratherapeutic Dose

EXPERIMENTAL

Single oral dose of 48mg CTP-543

Drug: CTP-543

Treatment D: Placebo

PLACEBO COMPARATOR

Single oral dose of 1 Placebo tablet

Drug: Placebo

Treatment C: Positive Control

ACTIVE COMPARATOR

Single oral dose of 400mg Moxifloxacin

Drug: Moxifloxacin

Interventions

CTP-543 DRUG

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

Treatment A: Therapeutic Dose

Moxifloxacin DRUG

Moxifloxacin (1 x 400 mg tablet) dosed with water

Treatment C: Positive Control

Placebo DRUG

Placebo (1 tablet) dosed with water

Treatment D: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (1)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 14, 2022
• Study Start: January 4, 2022
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

US (1)