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

Health Volunteers Clinical Trial

Official title:

A 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 of CTP-543 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05478772
• Other study ID #: CP543.1015
• Status: Completed
• Phase: Phase 1
• Start date: July 11, 2022
• Est. completion date: August 12, 2022

Study information

• Verified date: August 2022
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 12, 2022
• Est. primary completion date: August 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Volunteers

Intervention

Drug:
• CTP-543
12 mg on Day 1 and Day 7
• Fluconazole
200 mg once daily on Days 3 through to Day 8

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum observed concentration	Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Primary	Tmax	Time to reach maximum observed concentration	Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Primary	?z	Terminal elimination rate constant	Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Primary	t1/2	Apparent terminal half-life	Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Primary	AUC0-tlast	Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration	Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Primary	AUC0-inf	Area under the concentration-time curve from time 0 extrapolated to infinity	Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Secondary	Assessment of Safety and Tolerability following administration of CTP-543	Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject	Continuous from screening (within 21 days prior to Day 1) through Discharge (approximately 7 days after last study drug administration)