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

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CTP-543

About this trial

This is an interventional basic science trial for Hepatic Impairment focused on measuring CTP-543

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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 Hepatic Impairment:

For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9 at the time of screening. For mild hepatic impairment, the subject must have a Child- Pugh score of 5 to 6 at the time of screening.
No clinically significant change in disease status within the last 30 days before screening
The subject must have a condition consistent with hepatic impairment and associated symptoms, but otherwise be determined to be healthy in the opinion of the Investigator
If diabetic, the subject must have the disease controlled

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 GI 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.
Females who are nursing or pregnant prior to drug administration
Positive for human immunodeficiency virus (HIV)
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 Hepatic Impairment:

History or current diagnosis of uncontrolled or significant cardiac disease
Gilbert's syndrome, liver transplant, Wilson's disease, autoimmune liver disease, esophageal variceal bleeding within 3 months prior to screening
Previous diagnosis of hepatocellular carcinoma
Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function

Sites / Locations

Orlando Clinical Research Center
Alliance for Multispecialty Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CTP-543 Treatment - Mild Hepatic Impairment

CTP-543 Treatment - Moderate Hepatic Impairment

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

NCT05467722

First Posted

June 30, 2022

Last Updated

November 28, 2022

Sponsor

Concert Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05467722

Brief Title

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

Official Title

A Phase 1 Study to Assess the Effect of Mild and Moderate Hepatic 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 1, 2022 (Actual)

Primary Completion Date

September 15, 2022 (Actual)

Study Completion Date

September 21, 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

5. Study Description

Brief Summary

This is an open-label, single-dose, single-period, parallel group designed study to determine the effect of mild and moderate hepatic 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

Hepatic Impairment

Keywords

CTP-543

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CTP-543 Treatment - Mild Hepatic Impairment

Arm Type

Experimental

Arm Title

CTP-543 Treatment - Moderate Hepatic Impairment

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, 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, 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

Time Frame

0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 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 the final administration of study drug)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

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 Hepatic Impairment: For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9 at the time of screening. For mild hepatic impairment, the subject must have a Child- Pugh score of 5 to 6 at the time of screening. No clinically significant change in disease status within the last 30 days before screening The subject must have a condition consistent with hepatic impairment and associated symptoms, but otherwise be determined to be healthy in the opinion of the Investigator If diabetic, the subject must have the disease controlled 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 GI 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. Females who are nursing or pregnant prior to drug administration Positive for human immunodeficiency virus (HIV) 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 Hepatic Impairment: History or current diagnosis of uncontrolled or significant cardiac disease Gilbert's syndrome, liver transplant, Wilson's disease, autoimmune liver disease, esophageal variceal bleeding within 3 months prior to screening Previous diagnosis of hepatocellular carcinoma Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function

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 Hepatic Impairment on the Pharmacokinetics of CTP-543

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