- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092712
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
September 24, 2019 updated by: Concert Pharmaceuticals
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Celerion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Investigational Product
[14C]-CTP-543
|
Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
|
|
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
|
From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
|
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
|
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)
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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).
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
|
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)
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
|
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
|
Pre-dose up to 336 hours post-dose
|
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
|
Pre-dose up to 336 hours post-dose
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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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
|
|
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
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Screening up to Day 15
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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)
|
Screening, Pre-dose, 2, 8, 48 hours post-dose
|
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)
|
Screening, Pre-dose, 2, 8, 48 hours post-dose
|
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
|
Screening, Pre-dose, 2, 8, 48 hours post-dose
|
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)
|
Screening, Pre-dose, 2, 8, 48 hours post-dose
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Number of Participants With Clinically Significant Change From Baseline in Hematology
Time Frame: Screening, Check-in, 8, 24 hours postdose
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Screening, Check-in, 8, 24 hours postdose
|
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Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry
Time Frame: Screening, Check-in, 8, 24 hours postdose
|
Screening, Check-in, 8, 24 hours postdose
|
|
Number of Participants With Clinically Significant Change From Baseline in Coagulation
Time Frame: Screening, Check-in, 8, 24 hours postdose
|
Screening, Check-in, 8, 24 hours postdose
|
|
Number of Participants With Clinically Significant Change From Baseline in Urinalysis
Time Frame: Screening, Check-in, 8, 24 hours postdose
|
Screening, Check-in, 8, 24 hours postdose
|
|
Number of Participants With Clinically Significant Changes to the Physical Examination
Time Frame: Screening up to Day 15
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Clinically significant changes to the physical examination
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Screening up to Day 15
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Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave
Time Frame: Screening, Pre-dose, 48 hours post-dose
|
Screening, Pre-dose, 48 hours post-dose
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex
Time Frame: Screening, Pre-dose, 48 hours post-dose
|
Screening, Pre-dose, 48 hours post-dose
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval
Time Frame: Screening, Pre-dose, 48 hours post-dose
|
Screening, Pre-dose, 48 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 5, 2019
Primary Completion (ACTUAL)
September 11, 2019
Study Completion (ACTUAL)
September 20, 2019
Study Registration Dates
First Submitted
September 5, 2019
First Submitted That Met QC Criteria
September 13, 2019
First Posted (ACTUAL)
September 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CP543.1004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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