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

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

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

Study Overview

• Status: Completed
• Conditions: Health Volunteers
• Intervention / Treatment: Drug: CTP-543

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Concert Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2022
• Primary Completion (ACTUAL): June 26, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (ACTUAL): July 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: CTP-543
• Other Study ID Numbers: CP543.1011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No