Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence 1 Fed:Fasted Period 1: CTP-543 12 mg fed Period 2: CTP-543 12 mg fasted |
Drug: CTP-543
For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)
|
| Experimental: Sequence 2 Fasted:Fed Period 1: CTP-543 12 mg fasted Period 2: CTP-543 12 mg fed |
Drug: CTP-543
For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)
|
Outcome Measures
Primary Outcome Measures
- Bioavailability and Pharmacokinetic Profile of CTP-543: 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]
Maximum observed concentration
- Bioavailability and Pharmacokinetic Profile of CTP-543: 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]
Time to reach maximum observed concentration
- Bioavailability and Pharmacokinetic Profile of CTP-543: 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]
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: 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]
Area under the concentration-time curve from time 0 extrapolated to infinity
Secondary Outcome Measures
- 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]
Maximum observed concentration
- 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]
Time to reach maximum observed concentration
- 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]
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
- 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]
Area under the concentration-time curve from time 0 extrapolated to infinity
- Assessment of Safety and Tolerability following administration of CTP-543 [Screening through 7 to 10 days after final dose administration]
Number of adverse events including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy, adult, male or female, 18-60 years of age, inclusive
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Nonsmoker who has not used nicotine containing products for at least 3 months
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Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
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Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs
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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
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Capable of giving informed consent and complying with study procedures.
Exclusion Criteria:
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History or presence of clinically significant medical or psychiatric condition or disease
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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
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History or presence of alcohol or drug abuse within the past 2 years
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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
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History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF)
450 msec for males or QTcF > 470 msec for females
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Abnormal liver function at screening
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Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
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Positive results for coronavirus infection (COVID-19) at screening or check-in (Day -1)
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Positive drug or alcohol results at screening
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Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
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Participation in another clinical study within 30 days prior to, and 30 days after the first dosing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Pharmacology of Miami, LLC | Miami | Florida | United States | 33014 |
Sponsors and Collaborators
- Concert Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP543.1011