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

NCT ID: NCT05467722

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-09-21

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CTP-543 Treatment - Mild Hepatic Impairment

Group Type: EXPERIMENTAL

CTP-543

Intervention Type: DRUG

Single 12 mg oral dose administered on Day 1

CTP-543 Treatment - Moderate Hepatic Impairment

Group Type: EXPERIMENTAL

CTP-543

Intervention Type: DRUG

Single 12 mg oral dose administered on Day 1

Interventions

CTP-543

Single 12 mg oral dose administered on Day 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Concert Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

CP543.1013

Identifier Type: -

Identifier Source: org_study_id