Overview

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

Status:
Completed
Trial end date:
2021-04-05
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Concert Pharmaceuticals
Criteria
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