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

NCT ID: NCT05468749

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2022-10-27

Brief Summary

This is an open-label, single-dose, sequentially designed, single-period study to determine the effect of moderate renal 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

Renal Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CTP-543 Treatment

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

• eGFR of 30-59 mL/minute/1.73 m2 as calculated by the MDRD equation
• No clinically significant change in disease status within the last 30 days before screening
• The subject must have a condition consistent with renal impairment and associated symptoms, but otherwise be determined to be in good health in the opinion of the Investigator
• Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed with the exception of strong CYP3A4 inhibitors and inducers

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 gastrointestinal 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
• Positive for human immunodeficiency virus, Hepatitis B virus, or Hepatitis C virus
• Females who are nursing or pregnant prior to drug administration
• 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 of renal transplant
• Significant bleeding diathesis that could preclude multiple venipuncture or deep intramuscular injections
• Acute or exacerbating renal disease
• History of drugs of abuse or alcohol misuse within 6 months prior to screening
• Poorly controlled Type 1 or Type 2 diabetes

• 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

CP543.1014

Identifier Type: -

Identifier Source: org_study_id