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

NCT05467696 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Health Volunteers

Keywords

CTP-543

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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: 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

• 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: 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

• Assessment of Safety and Tolerability following administration of CTP-543

  Screening through 7 to 10 days after final dose administration

Study Arms (2)

Sequence 1 Fed:Fasted

EXPERIMENTAL

Period 1: CTP-543 12 mg fed Period 2: CTP-543 12 mg fasted

Drug: CTP-543

Sequence 2 Fasted:Fed

EXPERIMENTAL

Period 1: CTP-543 12 mg fasted Period 2: CTP-543 12 mg fed

Drug: CTP-543

Interventions

CTP-543 DRUG

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

Sequence 1 Fed:Fasted; Sequence 2 Fasted:Fed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (1)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 20, 2022
• Study Start: June 14, 2022
• Primary Completion: June 26, 2022
• Study Completion: July 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

US (1)