Cardiac Repolarization in Healthy SubjectsPhase 1NCT06161220
A TQT Study to Evaluate the Electrocardiographic Effects of Carbidopa in Healthy Subjects
A Phase 1 study testing Carbidopa capsule and Moxifloxacin Tablets, USP in people with Cardiac Repolarization in Healthy Subjects, run by Impax Laboratories, LLC at 1 site in United States.
Trial summary
The purpose of this trial is to assess the effects of a single supratherapeutic dose of carbidopa on cardiac repolarization relative to placebo in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Repolarization in Healthy Subjects
- What is being tested?
- Carbidopa capsule and Moxifloxacin Tablets, USP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 5 Dec 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 18 to 55 years (both inclusive)
- For female subjects of childbearing potential, use of double contraception method
- Body Mass Index (BMI) 18.5 to <30 kg/m² at Screening, with a minimum weight of 55kg
- Subject with no clinically significant abnormal serum biochemistry, hematology and urine examination values at screening
- Subject with negative urine screen for drugs of abuse at screening
- Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results at screening
Show all 9Show fewer
- Subject must be willing to communicate with the investigator and site staff and comply with all study procedures and requirements
- Subject must be able to provide written, informed consent including compliance with the requirements listed in the consent form
- Subject must be able and willing to swallow whole capsules without breaking, cutting, or chewing
Who cannot join
- History or presence of systemic diseases at Screening, which as judged by the investigator, may affect the outcome of this study, include, but not limited to significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Female subjects who are pregnant or lactating
- Knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders
- Resting supine heart rate less than 50 beats per minute or greater than 100 beats per minute
- Resting supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg; resting supine diastolic blood pressure less than 50 mmHg or greater than 90 mmHg.
- Clinically significant (as determined by the Investigator) ECG abnormalities at Screening, including:
Show all 30Show fewer
- QTcF > 450 ms for female and >430 ms for male
- QRS > 110 ms
- PR > 200 ms
- QTcF > 450 ms for female and >430 for male
- QRS > 110 ms
- PR > 200 ms
- Resting supine HR <50 beats per minute (bpm) or >100 bpm (may be repeated once at the discretion of the investigator)
- Second or third-degree AV block
- Any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant
- Bundle Branch Block
- premature atrial and ventricular contractions,
- nonspecific T-wave changes
- Positive urine/serum drug screen at Screening or Day -1 for each Period
- History of significant alcohol abuse or drug abuse within one year prior to Screening.
- Use of prescription medication (with the exception of medically approved hormonal contraceptives) including MAO inhibitors in the 30 days prior to admission into Period 1 and over-the-counter medications including vaccines, vitamins, and herbal remedies within 14 days prior to admission of Period 1 till completion of the study (EOS or ET)
- History of unexplained loss of consciousness, unexplained syncope, unexplained irregular heartbeats or palpitations or near drowning with hospital admission
- Subjects who received any investigational drug within the longer of 30 days or 5 half-lives of Day 1 dosing of SM
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study
- Use of medications in the 90 days before admission of the study that are known to prolong the QT/QTc interval.
- Family history of QTc prolongation or of unexplainable sudden death at <50 years of age. For this study, family is defined as 1st degree relative (i.e., mother, father, siblings, children) or 2nd degree relative (grandparents, grandchildren, half-siblings, aunt/uncle, niece/nephew).
- Subjects who cannot refrain from using tobacco of any kind within 30 days prior to admission (Day -1) of Period 1 until the last blood sample collection of study
- Subjects who cannot refrain from consumption of alcohol or alcohol containing products or xanthine-containing foods or beverages (like chocolate, tea, coffee or cola drinks) within 48 hours prior to admission (Day -1) of Period 1 till the last blood sample collection of study
- Subjects who participate in other drug research study during the study.
- Subjects who cannot refrain from donating blood or plasma for 30 days and 14 days (respectively) prior to dosing, during the study, and for at least 4 weeks after completing the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Way Crossover Thorough QT/QTc Study to Evaluate the Electrocardiographic Effects of a Supratherapeutic Dose of Carbidopa in Healthy Subjects
The purpose of this trial is to assess the effects of a single supratherapeutic dose of carbidopa on cardiac repolarization relative to placebo in healthy adult subjects.
- Being tested
- Carbidopa capsule, Moxifloxacin Tablets, USP, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbidopa capsuleDrug
Dose: 4x 100 mg
Moxifloxacin Tablets, USPDrug
Dose: 400 mg
PlaceboDrug
Placebo capsules matching the carbidopa capsules
| Study group | Role | What they receive |
|---|---|---|
| Carbidopa capsule | Experimental | Dose: 4x 100 mg Receives: Drug: Carbidopa capsule; Drug: Moxifloxacin Tablets, USP; Drug: Placebo |
| Moxifloxacin Tablets, USP | Active comparator | Dose: 400 mg Receives: Drug: Carbidopa capsule; Drug: Moxifloxacin Tablets, USP; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Carbidopa capsule; Drug: Moxifloxacin Tablets, USP; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline QTcF (ΔQTcF)
Change-from-baseline QTcF ( QTcF) will allow evaluation of the effects of carbidopa and moxifloxacin on cardiac repolarization based on model derived placebo-corrected ΔQTcF (ΔΔQTcF).
Measured: Predose to 24 hours postdose
Secondary outcomes (1)
Change from baseline HR, PR, and QRS
Change from baseline HR, PR, and QRS (ΔHR, ΔPR, ΔQRS) will also be measured to allow evaluation of the effects of carbidopa and moxifloxacin on other ECG parameters based on model derived placebo-corrected ΔHR, ΔPR, and ΔQRS (ΔΔHR, ΔΔPR, and ΔΔQRS).
Measured: Predose to 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start30 Oct 2023
- Primary completion3 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Repolarization in Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impax Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161220
- Sponsor's protocol ID
- IPX203-102-23
- Status last verified
- Mar 2024
- First submitted
- 30 Nov 2023
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Way Crossover Thorough QT/QTc Study to Evaluate the Electrocardiographic Effects of a Supratherapeutic Dose of Carbidopa in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06161220
- Acronym / sponsor ID
- IPX203-102-23
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Impax Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 7 Dec 2023 (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.
The purpose of this trial is to assess the effects of a single supratherapeutic dose of carbidopa on cardiac repolarization relative to placebo in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbidopa capsule | Experimental | Drug: Carbidopa capsule, Drug: Moxifloxacin Tablets, USP, Drug: PlaceboDose: 4x 100 mg |
| Moxifloxacin Tablets, USP | Active comparator | Drug: Carbidopa capsule, Drug: Moxifloxacin Tablets, USP, Drug: PlaceboDose: 400 mg |
| Placebo | Placebo comparator | Drug: Carbidopa capsule, Drug: Moxifloxacin Tablets, USP, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy males and females aged 18 to 55 years (both inclusive)
- For female subjects of childbearing potential, use of double contraception method
- Body Mass Index (BMI) 18.5 to <30 kg/m² at Screening, with a minimum weight of 55kg
- Subject with no clinically significant abnormal serum biochemistry, hematology and urine examination values at screening
- Subject with negative urine screen for drugs of abuse at screening
Key exclusion criteria (30 listed)
- History or presence of systemic diseases at Screening, which as judged by the investigator, may affect the outcome of this study, include, but not limited to significant: cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Female subjects who are pregnant or lactating
- Knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders
- Resting supine heart rate less than 50 beats per minute or greater than 100 beats per minute
- Resting supine systolic blood pressure less than 90 mmHg or greater than 140 mmHg; resting supine diastolic blood pressure less than 50 mmHg or greater than 90 mmHg.
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 |
|---|---|---|
| Carbidopa capsuleDose: 4x 100 mg | Drug | Carbidopa capsule, Moxifloxacin Tablets, USP, Placebo |
| Moxifloxacin Tablets, USPDose: 400 mg | Drug | Carbidopa capsule, Moxifloxacin Tablets, USP, Placebo |
| PlaceboPlacebo capsules matching the carbidopa capsules | Drug | Carbidopa capsule, Moxifloxacin Tablets, USP, Placebo |
Primary outcome
Change from baseline QTcF (ΔQTcF)
Time frame: Predose to 24 hours postdose
Change-from-baseline QTcF ( QTcF) will allow evaluation of the effects of carbidopa and moxifloxacin on cardiac repolarization based on model derived placebo-corrected ΔQTcF (ΔΔQTcF).
1 secondary outcome
Change from baseline HR, PR, and QRS
Time frame: Predose to 24 hours postdose
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 5 Mar 2024.
Related trials for Cardiac Repolarization in Healthy Subjects
RecruitingPhase 1
A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects
Healthy Adult Subject
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 Carbidopa capsule and Moxifloxacin Tablets, USP in people with Cardiac Repolarization in Healthy Subjects, run by Impax Laboratories, LLC 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 9 inclusion and 30 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 5 Mar 2024. 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?
Change from baseline QTcF (ΔQTcF) (time frame: Predose to 24 hours postdose). 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 5 Mar 2024.