Healthy VolunteersPhase 1NCT04092712
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
A Phase 1 study testing [14C]-CTP-543 in people with Healthy Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-CTP-543
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 20 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-CTP-543
- Keywords
- Mass Balance, Radiolabeled, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-CTP-543Drug
Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | [14C]-CTP-543 Receives: Drug: [14C]-CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance: Calculation of percent of total radioactivity recovered in urine
Measured: 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
Measured: From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15
CTP-543 PK: Cmax
Maximum plasma concentration
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 PK: Tmax
Time for Cmax
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 PK: t1/2
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 PK: AUClast
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 PK: AUCinf
Area under the plasma concentration time profile from time 0 to infinity
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
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).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 PK: Vz/F
Apparent volume of distribution following oral administration
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 metabolite PK: Cmax
Maximum plasma concentration
Measured: 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 for Cmax
Measured: 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
Measured: 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
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
CTP-543 metabolite PK: AUCinf
Area under the plasma concentration time profile from time 0 to infinity
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose
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
Measured: Pre-dose up to 336 hours post-dose
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
Measured: Pre-dose up to 336 hours post-dose
Total radioactivity in whole blood
Measured: 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
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Secondary outcomes (13)
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
Measured: Screening up to Day 15
Number of Participants With Clinically Significant Change From Baseline in Heart Rate
Heart rate measured in beats per minute (bpm)
Measured: Screening, Pre-dose, 2, 8, 48 hours post-dose
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure
Blood pressure measured in millimeters of mercury (mmHg)
Measured: Screening, Pre-dose, 2, 8, 48 hours post-dose
Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate
Respiratory rate measured in breaths per minute
Measured: Screening, Pre-dose, 2, 8, 48 hours post-dose
Number of Participants With Clinically Significant Change From Baseline in Temperature
Temperature measured in Celsius (°C)
Measured: Screening, Pre-dose, 2, 8, 48 hours post-dose
Number of Participants With Clinically Significant Change From Baseline in Hematology
Measured: Screening, Check-in, 8, 24 hours postdose
Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry
Measured: Screening, Check-in, 8, 24 hours postdose
Number of Participants With Clinically Significant Change From Baseline in Coagulation
Measured: Screening, Check-in, 8, 24 hours postdose
Number of Participants With Clinically Significant Change From Baseline in Urinalysis
Measured: Screening, Check-in, 8, 24 hours postdose
Number of Participants With Clinically Significant Changes to the Physical Examination
Clinically significant changes to the physical examination
Measured: Screening up to Day 15
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave
Measured: Screening, Pre-dose, 48 hours post-dose
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex
Measured: Screening, Pre-dose, 48 hours post-dose
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval
Measured: Screening, Pre-dose, 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start5 Sep 2019
- Primary completion11 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092712
- Sponsor's protocol ID
- CP543.1004
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04092712
- Acronym / sponsor ID
- CP543.1004
- Conditions
- Healthy Volunteers
- Keywords
- Mass Balance, Radiolabeled, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Drug: [14C]-CTP-543[14C]-CTP-543 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-CTP-543Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution | Drug | Investigational Product |
Primary outcome
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
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
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
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
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
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)
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
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).
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
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
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
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
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)
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
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
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
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
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
13 secondary outcomes
Adverse events
Time frame: Screening up to Day 15
Number of Participants With Clinically Significant Change From Baseline in Heart Rate
Time frame: 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
Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate
Time frame: 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
Number of Participants With Clinically Significant Change From Baseline in Hematology
Time frame: Screening, Check-in, 8, 24 hours postdose
Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry
Time frame: 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
Number of Participants With Clinically Significant Change From Baseline in Urinalysis
Time frame: 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
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave
Time frame: 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
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval
Time frame: Screening, Pre-dose, 48 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-CTP-543 in people with Healthy Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.