Clinical trial NCT05468749: Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543
Official title: A Phase 1 Study to Assess the Effect of Moderate Renal Impairment on the Pharmacokinetics of CTP-543 (Deuruxolitinib Phosphate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: CTP-543
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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

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

Primary outcomes:
measure: Single dose PK exposure: Maximum observed concentration (Cmax)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: 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:
measure: Assessment of Safety and Tolerability following administration of CTP-543
timeFrame: Screening (within 21 days prior to Day 1) through follow-up (7 to 10 days after final drug)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
Study officials:
References: