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

NCT05468749 | Completed Phase 1 FDA Drug

• 1 other identifier: CP543.1014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

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, 18, 24, 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, 18, 24, 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, 18, 24, 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 final drug)

Study Arms (1)

CTP-543 Treatment

EXPERIMENTAL

Drug: CTP-543

Interventions

CTP-543 DRUG

Single 12 mg oral dose administered on Day 1

CTP-543 Treatment

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
• 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

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 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

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

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 21, 2022
• Study Start: June 6, 2022
• Primary Completion: October 20, 2022
• Study Completion: October 27, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

US (2)