Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CTP-543 Treatment - Mild Hepatic Impairment
|
Drug: CTP-543
Single 12 mg oral dose administered on Day 1
|
| Experimental: CTP-543 Treatment - Moderate Hepatic Impairment
|
Drug: CTP-543
Single 12 mg oral dose administered on Day 1
|
Outcome Measures
Primary Outcome Measures
- Single dose PK exposure: Maximum observed concentration (Cmax) [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]
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) [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]
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) [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]
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 [Screening (within 21 days prior to Day 1) through follow-up (7 to 10 days after the final administration of study drug)]
Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Eligibility Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Clinical Research Center | Orlando | Florida | United States | 32809 |
| 2 | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | United States | 37920 |
Sponsors and Collaborators
- Concert Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP543.1013