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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04092712
Other study ID # CP543.1004
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 5, 2019
Est. completion date September 20, 2019

Study information

Verified date September 2019
Source Concert Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date September 20, 2019
Est. primary completion date September 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
[14C]-CTP-543
Single dose of radiolabeled CTP-543 (approximately 75 µCi) administered as an oral solution

Locations

Country Name City State
United States Celerion Lincoln Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Concert Pharmaceuticals Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mass balance: Calculation of percent of total radioactivity recovered in urine From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
Primary Mass balance: Calculation of percent of total radioactivity recovered in feces From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
Primary CTP-543 PK: Cmax Maximum plasma concentration Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 PK: Tmax Time for Cmax Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 PK: t1/2 Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 PK: AUClast Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast) Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 PK: AUCinf Area under the plasma concentration time profile from time 0 to infinity Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 PK: CL/F 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). Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 PK: Vz/F Apparent volume of distribution following oral administration Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 metabolite PK: Cmax Maximum plasma concentration Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 metabolite PK: Tmax Time for Cmax Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 metabolite PK: t1/2 Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 metabolite PK: AUC0-last Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast) Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary CTP-543 metabolite PK: AUCinf Area under the plasma concentration time profile from time 0 to infinity Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Primary Total [14C]: urine Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543 Pre-dose up to 336 hours post-dose
Primary Total [14C]: feces Total radioactivity excreted into the feces from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543 Pre-dose up to 336 hours post-dose
Primary Total radioactivity in whole blood Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Primary Total radioactivity in plasma Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Secondary Adverse events Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug Screening up to Day 15
Secondary Number of Participants With Clinically Significant Change From Baseline in Heart Rate Heart rate measured in beats per minute (bpm) Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary Number of Participants With Clinically Significant Change From Baseline in Blood Pressure Blood pressure measured in millimeters of mercury (mmHg) Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate Respiratory rate measured in breaths per minute Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary Number of Participants With Clinically Significant Change From Baseline in Temperature Temperature measured in Celsius (°C) Screening, Pre-dose, 2, 8, 48 hours post-dose
Secondary Number of Participants With Clinically Significant Change From Baseline in Hematology Screening, Check-in, 8, 24 hours postdose
Secondary Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry Screening, Check-in, 8, 24 hours postdose
Secondary Number of Participants With Clinically Significant Change From Baseline in Coagulation Screening, Check-in, 8, 24 hours postdose
Secondary Number of Participants With Clinically Significant Change From Baseline in Urinalysis Screening, Check-in, 8, 24 hours postdose
Secondary Number of Participants With Clinically Significant Changes to the Physical Examination Clinically significant changes to the physical examination Screening up to Day 15
Secondary Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave Screening, Pre-dose, 48 hours post-dose
Secondary Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex Screening, Pre-dose, 48 hours post-dose
Secondary Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval Screening, Pre-dose, 48 hours post-dose
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