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Completed

NCT Number: NCT05478772

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

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

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Key information

Conditions

Health Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTP-543

Drug

12 mg on Day 1 and Day 7

Fluconazole

Drug

200 mg once daily on Days 3 through to Day 8

Primary outcomes

  1. Cmax

    Time frame: 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

    Maximum observed concentration

  2. Tmax

    Time frame: 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

    Time to reach maximum observed concentration

  3. λz

    Time frame: 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

    Terminal elimination rate constant

  4. t1/2

    Time frame: 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

    Apparent terminal half-life

  5. AUC0-tlast

    Time frame: 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

    Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration

  6. AUC0-inf

    Time frame: 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

    Area under the concentration-time curve from time 0 extrapolated to infinity

Secondary outcomes

  1. Assessment of Safety and Tolerability following administration of CTP-543

    Time frame: Continuous from screening (within 21 days prior to Day 1) through Discharge (approximately 7 days after last study drug administration)

    Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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