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

Concert Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Treatments

Drug: CTP-543

Study type

Interventional

Funder types

Industry

Identifiers

NCT05468749

CP543.1014

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Additional Inclusion Criteria for Subjects with Renal Impairment:

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)

Additional Exclusion Criteria for Subjects with Renal Impairment:

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