Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

Concert Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Health Volunteers

Treatments

Drug: CTP-543

Study type

Interventional

Funder types

Industry

Identifiers

NCT05467696

CP543.1011

Details and patient eligibility

About

This is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

Enrollment

16 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy, adult, male or female, 18-60 years of age, inclusive
Nonsmoker who has not used nicotine containing products for at least 3 months
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 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication
Capable of giving informed consent and complying with study procedures.

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
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
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 (Day -1)
Positive drug or alcohol results at screening
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
Participation in another clinical study within 30 days prior to, and 30 days after the first dosing