Health VolunteersPhase 1NCT05467696
Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
A Phase 1 study testing CTP-543 in people with Health Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
Trial summary
This is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteers
- What is being tested?
- CTP-543
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 1 Jul 2022
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female, 18-60 years of age, inclusive
- Nonsmoker who has not used nicotine containing products for at least 3 months
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs
- If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks 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.
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of alcohol or drug abuse within the past 2 years
- Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females
- Abnormal liver function at screening
Show all 11Show fewer
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
- Positive results for coronavirus infection (COVID-19) at screening or check-in (Day -1)
- Positive drug or alcohol results at screening
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Participation in another clinical study within 30 days prior to, and 30 days after the first dosing
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
About this study
Official title: A Phase 1 Open-Label, Two-Period, Two-Treatment, Crossover Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
This is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
- Conditions
- Health Volunteers
- Being tested
- CTP-543
- Keywords
- CTP-543
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-543Drug
For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 Fed:Fasted | Experimental | Period 1: CTP-543 12 mg fed Period 2: CTP-543 12 mg fasted Receives: Drug: CTP-543 |
| Sequence 2 Fasted:Fed | Experimental | Period 1: CTP-543 12 mg fasted Period 2: CTP-543 12 mg fed Receives: Drug: CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax
Maximum observed concentration
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Bioavailability and Pharmacokinetic Profile of CTP-543: Tmax
Time to reach maximum observed concentration
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-Tlast)
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-inf)
Area under the concentration-time curve from time 0 extrapolated to infinity
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Secondary outcomes (5)
Pharmacokinetic Profile of major metabolites: Cmax
Maximum observed concentration
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: Tmax
Time to reach maximum observed concentration
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: AUC(0-Tlast)
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: AUC(0-inf)
Area under the concentration-time curve from time 0 extrapolated to infinity
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Assessment of Safety and Tolerability following administration of CTP-543
Number of adverse events including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Measured: Screening through 7 to 10 days after final dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start14 Jun 2022
- Primary completion26 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467696
- Sponsor's protocol ID
- CP543.1011
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 20 Jul 2022
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Two-Period, Two-Treatment, Crossover Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05467696
- Acronym / sponsor ID
- CP543.1011
- Conditions
- Health Volunteers
- Keywords
- CTP-543
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 26 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 20 Jul 2022 (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 is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 Fed:Fasted | Experimental | Drug: CTP-543Period 1: CTP-543 12 mg fed Period 2: CTP-543 12 mg fasted |
| Sequence 2 Fasted:Fed | Experimental | Drug: CTP-543Period 1: CTP-543 12 mg fasted Period 2: CTP-543 12 mg fed |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, adult, male or female, 18-60 years of age, inclusive
- Nonsmoker who has not used nicotine containing products for at least 3 months
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs
- If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication
Key exclusion criteria (11 listed)
- History or presence of clinically significant medical or psychiatric condition or disease
- History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of alcohol or drug abuse within the past 2 years
- Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females
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 |
|---|---|---|
| CTP-543For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet) | Drug | Sequence 1 Fed:Fasted, Sequence 2 Fasted:Fed |
Primary outcome
Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Maximum observed concentration
Bioavailability and Pharmacokinetic Profile of CTP-543: Tmax
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Time to reach maximum observed concentration
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-Tlast)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-inf)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Area under the concentration-time curve from time 0 extrapolated to infinity
5 secondary outcomes
Pharmacokinetic Profile of major metabolites: Cmax
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: Tmax
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: AUC(0-Tlast)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: AUC(0-inf)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Assessment of Safety and Tolerability following administration of CTP-543
Time frame: Screening through 7 to 10 days after final dose administration
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 20 Jul 2022.
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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 CTP-543 in people with Health 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 6 inclusion and 11 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 20 Jul 2022. 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?
Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax (time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge). The study lists 4 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 20 Jul 2022.