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

NCT04843540 — Phase 1, Completed, 22 participants, Concert Pharmaceuticals

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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

RegistryNCT04843540
StatusCompleted
PhasePhase 1
Study typeInterventional; na, sequential, masking: none, other
Enrollment22 (Actual)
SponsorConcert Pharmaceuticals (Industry)
ConditionsHealthy Volunteers
InterventionsCTP-543 (Drug)
Datesstart 2021-05-19, primary completion 2021-06-24, completion 2021-07-02, first posted 2021-04-13, last updated 2021-07-20
Locations1 site in United States

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
CTP-543ExperimentalDrug: CTP-543On 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 rifampin on Day 4 through Day 15, with a single oral dose of CTP-543 being co-administered on Day 14.
  • CTP-543 (Drug): Rifampin as oral capsule

+Outcome measures

Primary outcomes

  • AUC0-t [16 hours]: Area Under the Plasma Concentration-Time Profile
  • AUC0-inf [16 hours]: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time
  • Cmax [16 hours]: Maximum observed concentration of drug in plasma
  • Tmax [16 hours]: Time to reach maximum observed concentration of drug in plasma

Secondary outcomes

  • Number of Participants with Adverse Events (AEs) [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

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Clinical Pharmacology of MiamiMiami, FloridaUnited States

My Notes