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Completed

NCT Number: NCT04092712

Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers

This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of [14C]-CTP-543 in healthy male subjects.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects between the ages of 19 and 55 years, inclusive (healthy is determined by medical evaluation, including medical history, full physical examination, vital signs, electrocardiogram, and clinical laboratory tests)
  • Body Mass Index of 18.0 to 32.0 kg/m2
  • Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing and throughout the study

Exclusion criteria

  • Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening
  • Infection with hepatitis B or hepatitis C viruses
  • History of irregular bowel movements
  • History of herpes zoster
  • A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
  • History or presence of alcoholism or drug abuse within the past 2 years prior to dosing
  • Participation in another clinical study within 30 days prior to dosing

Treatment and study plan

[14C]-CTP-543

Drug

Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution

Primary outcomes

  1. Mass balance: Calculation of percent of total radioactivity recovered in urine

    Time frame: From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15

  2. Mass balance: Calculation of percent of total radioactivity recovered in feces

    Time frame: From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15

  3. CTP-543 PK: Cmax

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Maximum plasma concentration

  4. CTP-543 PK: Tmax

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Time for Cmax

  5. CTP-543 PK: t1/2

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

  6. CTP-543 PK: AUClast

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)

  7. CTP-543 PK: AUCinf

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Area under the plasma concentration time profile from time 0 to infinity

  8. CTP-543 PK: CL/F

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).

  9. CTP-543 PK: Vz/F

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Apparent volume of distribution following oral administration

  10. CTP-543 metabolite PK: Cmax

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Maximum plasma concentration

  11. CTP-543 metabolite PK: Tmax

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Time for Cmax

  12. CTP-543 metabolite PK: t1/2

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

  13. CTP-543 metabolite PK: AUC0-last

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)

  14. CTP-543 metabolite PK: AUCinf

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose

    Area under the plasma concentration time profile from time 0 to infinity

  15. Total [14C]: urine

    Time frame: Pre-dose up to 336 hours post-dose

    Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543

  16. Total [14C]: feces

    Time frame: Pre-dose up to 336 hours post-dose

    Total radioactivity excreted into the feces from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543

  17. Total radioactivity in whole blood

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose

  18. Total radioactivity in plasma

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose

Secondary outcomes

  1. Adverse events

    Time frame: Screening up to Day 15

    Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug

  2. Number of Participants With Clinically Significant Change From Baseline in Heart Rate

    Time frame: Screening, Pre-dose, 2, 8, 48 hours post-dose

    Heart rate measured in beats per minute (bpm)

  3. Number of Participants With Clinically Significant Change From Baseline in Blood Pressure

    Time frame: Screening, Pre-dose, 2, 8, 48 hours post-dose

    Blood pressure measured in millimeters of mercury (mmHg)

  4. Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate

    Time frame: Screening, Pre-dose, 2, 8, 48 hours post-dose

    Respiratory rate measured in breaths per minute

  5. Number of Participants With Clinically Significant Change From Baseline in Temperature

    Time frame: Screening, Pre-dose, 2, 8, 48 hours post-dose

    Temperature measured in Celsius (°C)

  6. Number of Participants With Clinically Significant Change From Baseline in Hematology

    Time frame: Screening, Check-in, 8, 24 hours postdose

  7. Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry

    Time frame: Screening, Check-in, 8, 24 hours postdose

  8. Number of Participants With Clinically Significant Change From Baseline in Coagulation

    Time frame: Screening, Check-in, 8, 24 hours postdose

  9. Number of Participants With Clinically Significant Change From Baseline in Urinalysis

    Time frame: Screening, Check-in, 8, 24 hours postdose

  10. Number of Participants With Clinically Significant Changes to the Physical Examination

    Time frame: Screening up to Day 15

    Clinically significant changes to the physical examination

  11. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave

    Time frame: Screening, Pre-dose, 48 hours post-dose

  12. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex

    Time frame: Screening, Pre-dose, 48 hours post-dose

  13. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval

    Time frame: Screening, Pre-dose, 48 hours post-dose

Sponsors and collaborators

Lead sponsor

Concert Pharmaceuticals

Industry

Collaborators

  • Celerion

Registry information

Official study title

A Phase 1, Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Oral [14C]-CTP-543 in Healthy Adult Male Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2019
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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