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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CTP-543

• Registration Number: NCT04743414
• Lead Sponsor: Concert Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-08
• Study Start: 2021-03-02
• Primary Completion: 2021-03-27
• Status Verified: 2021-04
• Study Completion: 2021-04-05
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CTP-543	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Up to 40 days	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

Trial Locations

Locations (1)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States