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

Health Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467696
• Other study ID #: CP543.1011
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 1, 2022
• Est. primary completion date: June 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Volunteers

Intervention

Drug:
• CTP-543
For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax	Maximum observed concentration	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
Primary	Bioavailability and Pharmacokinetic Profile of CTP-543: Tmax	Time to reach maximum observed concentration	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
Primary	Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-Tlast)	Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration	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
Primary	Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-inf)	Area under the concentration-time curve from time 0 extrapolated to infinity	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
Secondary	Pharmacokinetic Profile of major metabolites: Cmax	Maximum observed concentration	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
Secondary	Pharmacokinetic Profile of major metabolites: Tmax	Time to reach maximum observed concentration	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
Secondary	Pharmacokinetic Profile of major metabolites: AUC(0-Tlast)	Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration	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
Secondary	Pharmacokinetic Profile of major metabolites: AUC(0-inf)	Area under the concentration-time curve from time 0 extrapolated to infinity	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
Secondary	Assessment of Safety and Tolerability following administration of CTP-543	Number of adverse events including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject	Screening through 7 to 10 days after final dose administration