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

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05468749
• Collaborator: (none)
• Enrollment: 16
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 2.9
• Patients Per Site: 8
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment	Drug: CTP-543	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1 Study to Assess the Effect of Moderate Renal Impairment on the Pharmacokinetics of CTP-543 (Deuruxolitinib Phosphate)
• Actual Study Start Date: Jun 6, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTP-543 Treatment	Drug: CTP-543; Single 12 mg oral dose administered on Day 1

Outcome Measures

Primary Outcome Measures

1. 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, 18, 24, 36, 48 hours post-dose]

   Maximum concentration, obtained directly from the observed concentration versus time data.

2. 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, 18, 24, 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)

3. 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, 18, 24, 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

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)]

   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

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05468749
• Other Study ID Numbers: CP543.1014
• First Posted: Jul 21, 2022
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Concert Pharmaceuticals: CTP-543
• Additional relevant MeSH terms: Renal Insufficiency

Study Results

No Results Posted as of Jul 21, 2022