A Phase 1 Open-Label, Two-Period, Two-Treatment, Crossover Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- CTP-543
- Conditions
- Health Volunteers
- Sponsor
- Concert Pharmaceuticals
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Bioavailability and Pharmacokinetic Profile of CTP-543: Tmax
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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)
Arms & Interventions
Sequence 1 Fed:Fasted
Period 1: CTP-543 12 mg fed Period 2: CTP-543 12 mg fasted
Intervention: CTP-543
Sequence 2 Fasted:Fed
Period 1: CTP-543 12 mg fasted Period 2: CTP-543 12 mg fed
Intervention: CTP-543
Outcomes
Primary Outcomes
Bioavailability and Pharmacokinetic Profile of CTP-543: Tmax
Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Time to reach maximum observed concentration
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-inf)
Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Area under the concentration-time curve from time 0 extrapolated to infinity
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-Tlast)
Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax
Time Frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Maximum observed concentration
Secondary Outcomes
- Pharmacokinetic Profile of major metabolites: AUC(0-inf)(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge)
- Pharmacokinetic Profile of major metabolites: Cmax(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge)
- Pharmacokinetic Profile of major metabolites: AUC(0-Tlast)(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge)
- Pharmacokinetic Profile of major metabolites: Tmax(0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge)
- Assessment of Safety and Tolerability following administration of CTP-543(Screening through 7 to 10 days after final dose administration)