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

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05192369
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 4
• Actual Duration (Days): 24
• Patients Per Site Per Month: 60.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: CTP-543; Drug: CTP-543; Drug: Moxifloxacin; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 4, 2022
• Actual Primary Completion Date: Jan 28, 2022
• Actual Study Completion Date: Jan 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A: Therapeutic Dose Single oral dose of 12mg CTP-543	Drug: CTP-543; CTP-543 12 mg (1 x 12 mg tablet), dosed with water
Experimental: Treatment B: Supratherapeutic Dose Single oral dose of 48mg CTP-543	Drug: CTP-543; CTP-543 48 mg (4 x 12 mg tablet) dosed with water
Placebo Comparator: Treatment D: Placebo Single oral dose of 1 Placebo tablet	Drug: Placebo; Placebo (1 tablet) dosed with water
Active Comparator: Treatment C: Positive Control Single oral dose of 400mg Moxifloxacin	Drug: Moxifloxacin; Moxifloxacin (1 x 400 mg tablet) dosed with water

Outcome Measures

Primary Outcome Measures

1. TQT Analysis [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami, LLC	Miami	Florida	United States	33014

Sponsors and Collaborators

• Concert Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05192369
• Other Study ID Numbers: CP543.1010
• First Posted: Jan 14, 2022
• Last Update Posted: Mar 4, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Concert Pharmaceuticals: CTP-543
• Additional relevant MeSH terms: Moxifloxacin

Study Results

No Results Posted as of Mar 4, 2022