Healthy VolunteersPhase 1NCT05192369
A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
A Phase 1 study testing CTP-543 and Moxifloxacin in people with Healthy Volunteers, run by Concert Pharmaceuticals at 1 site in United States.
Trial summary
This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals 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
- Healthy Volunteers
- What is being tested?
- CTP-543 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 28 Jan 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, non-smoking, adult males or females aged 18-60
- Body mass index of 18 to 32 mg/m2 at Screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or Electrocardiograms (ECGs)
- If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
- Understands the study procedures in the informed consent form and be willing and able to comply with the protocol
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 prior to the first dosing
- History of prolonged QT syndrome or a Corrected QT-interval (QTc) with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females obtained at Screening visit or prior to the first dosing
- 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 at Screening for human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus
- A positive test or history of incompletely treated or untreated tuberculosis
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 Four-Arm, Randomized, Crossover, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Doses of CTP-543 on the QT/QTc Intervals in Healthy Volunteers
This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers
- Conditions
- Healthy Volunteers
- Being tested
- CTP-543, Moxifloxacin, Placebo
- Keywords
- CTP-543
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-543Drug
CTP-543 12 mg (1 x 12 mg tablet), dosed with water
CTP-543Drug
CTP-543 48 mg (4 x 12 mg tablet) dosed with water
MoxifloxacinDrug
Moxifloxacin (1 x 400 mg tablet) dosed with water
PlaceboDrug
Placebo (1 tablet) dosed with water
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Therapeutic Dose | Experimental | Single oral dose of 12mg CTP-543 Receives: Drug: CTP-543 |
| Treatment B: Supratherapeutic Dose | Experimental | Single oral dose of 48mg CTP-543 Receives: Drug: CTP-543 |
| Treatment D: Placebo | Placebo comparator | Single oral dose of 1 Placebo tablet Receives: Drug: Placebo |
| Treatment C: Positive Control | Active comparator | Single oral dose of 400mg Moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
TQT Analysis
Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint
Measured: Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start4 Jan 2022
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 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
- NCT05192369
- Sponsor's protocol ID
- CP543.1010
- Status last verified
- Feb 2022
- First submitted
- 5 Jan 2022
- Last updated
- 4 Mar 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Arm, Randomized, Crossover, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Doses of CTP-543 on the QT/QTc Intervals in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05192369
- Acronym / sponsor ID
- CP543.1010
- Conditions
- Healthy Volunteers
- Keywords
- CTP-543
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 14 Jan 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 a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Therapeutic Dose | Experimental | Drug: CTP-543Single oral dose of 12mg CTP-543 |
| Treatment B: Supratherapeutic Dose | Experimental | Drug: CTP-543Single oral dose of 48mg CTP-543 |
| Treatment D: Placebo | Placebo comparator | Drug: PlaceboSingle oral dose of 1 Placebo tablet |
| Treatment C: Positive Control | Active comparator | Drug: MoxifloxacinSingle oral dose of 400mg Moxifloxacin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, non-smoking, adult males or females aged 18-60
- Body mass index of 18 to 32 mg/m2 at Screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or Electrocardiograms (ECGs)
- If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
- Understands the study procedures in the informed consent form and be willing and able to comply with the protocol
Key exclusion criteria (7 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 prior to the first dosing
- History of prolonged QT syndrome or a Corrected QT-interval (QTc) with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females obtained at Screening visit or prior to the first dosing
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
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-543CTP-543 12 mg (1 x 12 mg tablet), dosed with water | Drug | Treatment A: Therapeutic Dose |
| CTP-543CTP-543 48 mg (4 x 12 mg tablet) dosed with water | Drug | Treatment B: Supratherapeutic Dose |
| MoxifloxacinMoxifloxacin (1 x 400 mg tablet) dosed with water | Drug | Treatment C: Positive Control |
| PlaceboPlacebo (1 tablet) dosed with water | Drug | Treatment D: Placebo |
Primary outcome
TQT Analysis
Time frame: Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10
Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint
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 4 Mar 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 and Moxifloxacin 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 5 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 4 Mar 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. Some participants in this study may receive a placebo. 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?
TQT Analysis (time frame: Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10). 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 4 Mar 2022.