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Completed

NCT Number: NCT04843540

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

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami

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

  • 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

Treatment and study plan

CTP-543

Drug

Rifampin as oral capsule

Primary outcomes

  1. AUC0-t

    Time frame: 16 hours

    Area Under the Plasma Concentration-Time Profile

  2. AUC0-inf

    Time frame: 16 hours

    Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time

  3. Cmax

    Time frame: 16 hours

    Maximum observed concentration of drug in plasma

  4. Tmax

    Time frame: 16 hours

    Time to reach maximum observed concentration of drug in plasma

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 47 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

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Jul 20, 2021

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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