Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects

NCT ID: NCT05478772

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2022-08-12

Brief Summary

A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy subjects

Conditions

Health Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CTP-543 and Fluconazole Treatment

On Day 1, each subject will receive a single oral dose of 12 mg CTP-543. Following a washout on Day 2, each subject will receive an oral dose of 200 mg fluconazole once daily on Days 3 through to Day 8. On Day 7, approximately 1 hour after the 200 mg dose of fluconazole, each subject will receive a single oral dose of 12 mg CTP-543.

Group Type: EXPERIMENTAL

CTP-543

Intervention Type: DRUG

12 mg on Day 1 and Day 7

Fluconazole

Intervention Type: DRUG

200 mg once daily on Days 3 through to Day 8

Interventions

CTP-543

12 mg on Day 1 and Day 7

Intervention Type: DRUG

Fluconazole

200 mg once daily on Days 3 through to Day 8

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy, adult, male or female, aged 18-60 inclusive
• Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
• If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks 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 (ICF), 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 or presence of alcohol or drug abuse within the past 2 years
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
• Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
• History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females at Screening visit or prior to the first dosing
• Abnormal liver function at Screening
• 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 for coronavirus infection (COVID-19) at Screening or check-in
• Positive drug or alcohol results at Screening or check-in
• Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
• Vaccination with a live attenuated vaccine up to 6 weeks prior to dosing. Live vaccines include (but are not limited to) the measles, mumps, and rubella (MMR) vaccine; intranasal flu vaccine; and Zostavax for herpes zoster

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Concert Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States

Countries

United States

Other Identifiers

CP543.1015

Identifier Type: -

Identifier Source: org_study_id