Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543
Primary Purpose
Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CTP-543
Sponsored by
About this trial
This is an interventional basic science trial for Renal Impairment focused on measuring 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
Sites / Locations
- Orlando Clinical Research Center
- Alliance for Multispecialty Research, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CTP-543 Treatment
Arm Description
Outcomes
Primary Outcome Measures
Single dose PK exposure: Maximum observed concentration (Cmax)
Maximum concentration, obtained directly from the observed concentration versus time data.
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)
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
Secondary Outcome Measures
Assessment of Safety and Tolerability following administration of CTP-543
Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Full Information
NCT ID
NCT05468749
First Posted
June 30, 2022
Last Updated
November 28, 2022
Sponsor
Concert Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05468749
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
CTP-543
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTP-543 Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CTP-543
Intervention Description
Single 12 mg oral dose administered on Day 1
Primary Outcome Measure Information:
Title
Single dose PK exposure: Maximum observed concentration (Cmax)
Description
Maximum concentration, obtained directly from the observed concentration versus time data.
Time Frame
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
Title
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)
Description
Area under the concentration-time curve from time zero (pre-dose) to time of last measurable concentration (calculated by linear-log trapezoidal summation)
Time Frame
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
Title
Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf)
Description
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
Time Frame
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 Outcome Measure Information:
Title
Assessment of Safety and Tolerability following administration of CTP-543
Description
Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Time Frame
Screening (within 21 days prior to Day 1) through follow-up (7 to 10 days after final drug)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
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Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543
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