QT/QTc Interval in Healthy VolunteersPhase 1NCT03554304
Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
A Phase 1 study testing WCK 5222 and Moxifloxacin 400-mg in people with QT/QTc Interval in Healthy Volunteers, run by Wockhardt at 1 site in United States.
Trial summary
A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- QT/QTc Interval in Healthy Volunteers
- What is being tested?
- WCK 5222 and Moxifloxacin 400-mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2017to 6 Oct 2017
- 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
- Body mass index ≥18 to ≤33 kg/m2, inclusive.
- Stable health based on a medical history without any major pathology/surgery in the 6 months
Who cannot join
- An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block
- History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypocalcemia, or hypomagnesemia.
- A sustained supine systolic blood pressure >150 mm Hg or <90 mm Hg or a supine diastolic blood pressure >95 mm Hg or <50 mm Hg at Screening or Check-in (Day -1).
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
- Conditions
- QT/QTc Interval in Healthy Volunteers
- Being tested
- WCK 5222, IV placebo matched to WCK 5222 / Moxifloxacin IV solution, Moxifloxacin 400-mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCK 5222Drug
FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)
IV placebo matched to WCK 5222 / Moxifloxacin IV solutionDrug
Also called Placebo capsule matched to moxifloxacin
Placebo (IV placebo matched to FEP-ZID IV solution) and
1 placebo capsule matched to moxifloxacin overencapsulated tablet
Moxifloxacin 400-mgDrug
Moxifloxacin 400-mg positive control (overencapsulated tablet)
| Study group | Role | What they receive |
|---|---|---|
| WCK 5222 | Experimental | WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion) Receives: Drug: WCK 5222; Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution |
| Placebo (IV placebo matched toWCK 5222IV solution) | Placebo comparator | placebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution Receives: Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution |
| Moxifloxacin 400-mg | Active comparator | positive control Receives: Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution; Drug: Moxifloxacin 400-mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delay in cardiac repolarization induced by WCK 5222
as shown by analysis of the QT interval.
Measured: 0-4 days
Secondary outcomes (2)
Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation
Tolerability will be assessed by review of number of AEs
Measured: 0-4 days
Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID
Safety will be assessed by review of adverse events (AEs), ECGs, and clinical laboratory safety test results
Measured: 0-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start9 Feb 2017
- Primary completion5 Jun 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QT/QTc Interval in 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554304
- Sponsor's protocol ID
- W-5222-103
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03554304
- Acronym / sponsor ID
- W-5222-103
- Conditions
- QT/QTc Interval in Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 13 Jun 2018 (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.
A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WCK 5222 | Experimental | Drug: WCK 5222, Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solutionWCK 5222 IV solution administered as either a 30- or 60-minute IV infusion) |
| Placebo (IV placebo matched toWCK 5222IV solution) | Placebo comparator | Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solutionplacebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution |
| Moxifloxacin 400-mg | Active comparator | Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution, Drug: Moxifloxacin 400-mgpositive control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index ≥18 to ≤33 kg/m2, inclusive.
- Stable health based on a medical history without any major pathology/surgery in the 6 months
Key exclusion criteria (3 listed)
- An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block
- History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypocalcemia, or hypomagnesemia.
- A sustained supine systolic blood pressure >150 mm Hg or <90 mm Hg or a supine diastolic blood pressure >95 mm Hg or <50 mm Hg at Screening or Check-in (Day -1).
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 |
|---|---|---|
| WCK 5222FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion) | Drug | WCK 5222 |
| IV placebo matched to WCK 5222 / Moxifloxacin IV solutionAlso: Placebo capsule matched to moxifloxacinPlacebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet | Drug | Moxifloxacin 400-mg, Placebo (IV placebo matched toWCK 5222IV solution), WCK 5222 |
| Moxifloxacin 400-mgMoxifloxacin 400-mg positive control (overencapsulated tablet) | Drug | Moxifloxacin 400-mg |
Primary outcome
Incidence of delay in cardiac repolarization induced by WCK 5222
Time frame: 0-4 days
as shown by analysis of the QT interval.
2 secondary outcomes
Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation
Time frame: 0-4 days
Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID
Time frame: 0-4 days
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 13 Jun 2018.
- Individual participant dataSharing planned: No
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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 WCK 5222 and Moxifloxacin 400-mg in people with QT/QTc Interval in Healthy Volunteers, run by Wockhardt 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 2 inclusion and 3 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 13 Jun 2018. 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?
Incidence of delay in cardiac repolarization induced by WCK 5222 (time frame: 0-4 days). 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 13 Jun 2018.