Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects

A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inhibitor, Itraconazole, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects

This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CTP-543

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or 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
• 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 (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
• A positive test or history of incompletely treated or untreated tuberculosis
• Donation of > 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CTP-543; On Day 1, participants will receive a single oral dose of CTP-543. Following a washout period on Days 2 and 3, participants will receive a single oral dose of itraconazole on Day 4 through Day 8, with a single oral dose of CTP-543 being co-administered on Day 7.	Drug: CTP-543; Itraconazole in solution dosage form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Area Under the Plasma Concentration-Time Profile	48 hours
AUC0-inf	Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time	48 hours
Cmax	Maximum observed concentration of drug in plasma	48 hours
Tmax	Time to reach maximum observed concentration of drug in plasma	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention	Up to 40 days

Collaborators and Investigators

• Sponsor: Concert Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2021
• Primary Completion (ACTUAL): March 27, 2021
• Study Completion (ACTUAL): April 5, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (ACTUAL): February 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Itraconazole; CTP-543; Drug-drug interaction
• Other Study ID Numbers: CP543.1007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No