Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543

NCT05467722 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, single-dose, single-period, parallel group designed study to determine the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.

Conditions

Hepatic Impairment

Keywords

CTP-543

Outcome Measures

Primary Outcomes (3)

• Single dose PK exposure: Maximum observed concentration (Cmax)

  Maximum concentration, obtained directly from the observed concentration versus time data.

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 36, 48 hours post-dose

• Single dose PK exposure: Area Under the Concentration-Time Curve from time zero to the time of the last observed/measured non-zero concentration (AUC0-t)

  Area under the concentration-time curve from time zero (pre-dose) to time of last measurable concentration (calculated by linear-log trapezoidal summation)

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 36, 48 hours post-dose

• Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf)

  Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the elimination rate constant

  0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 36, 48 hours post-dose

Secondary Outcomes (1)

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

  Screening (within 21 days prior to Day 1) through follow-up (7 to 10 days after the final administration of study drug)

Study Arms (2)

CTP-543 Treatment - Mild Hepatic Impairment

EXPERIMENTAL

Drug: CTP-543

CTP-543 Treatment - Moderate Hepatic Impairment

EXPERIMENTAL

Drug: CTP-543

Interventions

CTP-543 DRUG

Single 12 mg oral dose administered on Day 1

CTP-543 Treatment - Mild Hepatic Impairment; CTP-543 Treatment - Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females aged 18-75
• Body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening
• If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days 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
• For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9 at the time of screening. For mild hepatic impairment, the subject must have a Child- Pugh score of 5 to 6 at the time of screening.
• No clinically significant change in disease status within the last 30 days before screening
• The subject must have a condition consistent with hepatic impairment and associated symptoms, but otherwise be determined to be healthy in the opinion of the Investigator
• If diabetic, the subject must have the disease controlled

You may not qualify if:

• History of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
• Known history of any GI surgery or any condition possibly affecting drug absorption
• History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 470 msec for males or QTcF \> 480 msec for females at Screening visit.
• Females who are nursing or pregnant prior to drug administration
• Positive for human immunodeficiency virus (HIV)
• Positive results for coronavirus infection (COVID-19) at screening or check-in
• Positive drugs of abuse or alcohol results at screening or check in (Day -1)
• History or current diagnosis of uncontrolled or significant cardiac disease
• Gilbert's syndrome, liver transplant, Wilson's disease, autoimmune liver disease, esophageal variceal bleeding within 3 months prior to screening
• Previous diagnosis of hepatocellular carcinoma
• Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 20, 2022
• Study Start: June 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 21, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

US (2)