Qt Interval, Variation inPhase 1NCT02217930
Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers
A Phase 1 study testing WCK 2349 and Moxifloxacin in people with Qt Interval, Variation in, run by Wockhardt at 1 site in United States.
Trial summary
The study designed to determine the effect induced by WCK 2349 on the QT interval. The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2) to assess the safety of high doses of single-dose administration of WCK 2349 on the QT interval. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Qt Interval, Variation in
- What is being tested?
- WCK 2349 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2015
- 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
- Male or female subject between 18 and 55 years of age,inclusive, with a body mass index ≥18 to ≤33 kg/m2.
- Female subjects must be at least 2 years postmenopausal,surgically sterile, or practicing 2 highly effective methods of birth control (determined by the investigator or designee; one of the methods must be a barrier technique), not pregnant or lactating, and have a negative serum pregnancy test before enrolling in the study.
- Male or female subjects must agree to practice 2 highly effective methods of birth control (as determined by the investigator or designee; one of the methods must be a barrier technique) from Screening until 30 days after the last dose of study drug.
- Stable health based on no clinically significant findings on the medical history, physical examination, or clinical laboratory test results (as determined and documented by the investigator).
- Willing to comply with all study activities and procedures and provides written informed consent prior to any study procedures.
Who cannot join
- An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval >110 milliseconds (msec); QT interval corrected by Fridericia's formula (QTcF) >430 msec (males) and >450 msec (females); PR interval >200 msec; heart rate (HR) <45 bpm; or any rhythm other than sinus rhythm that is interpreted by the investigator to be clinically significant.
- 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, hypercalcemia, or hypomagnesemia. Subjects will also be excluded if there is a family history of long QT syndrome or Brugada syndrome.
- 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). Blood pressure may be retested once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 2 assessments, and the subject may not be randomized.
- A resting HR of <40 beats per minute or >100 beats per minute when vital signs are measured at Screening or Check-in (Day -1).
- Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
- Uncontrolled hypertension, asthma, unstable diabetes (type I or type II), thyroid disease, seizures, myasthenia gravis, or any other neuromuscular disorder.
- Women who are pregnant (or planning to become pregnant within the next 6 months) or currently breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Phase 1 unit : Spaulding Clinical Research, LLC
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 2349 on the QT/QTc Interval in Health Volunteers
The study designed to determine the effect induced by WCK 2349 on the QT interval.
The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2) to assess the safety of high doses of single-dose administration of WCK 2349 on the QT interval.
Read the detailed description
Part 1 of this study will determine the supratherapeutic dose to be used in Part 2. Part 1will enroll 8 subjects at each of 4 dose levels (up to 32 subjects). Cohorts will be staggered so that appropriate safety monitoring and follow-up can be performed for each subject at each dose level.
Safety monitoring will be based upon review of AEs, ECGs and clinical laboratory test results prior to escalation to the next dose level.
At the first dose level, 6 subjects will be randomly assigned to receive a single dose of WCK 2349 at 1800 mg and 2 subjects will be randomly assigned to placebo. If this dose is tolerated by subjects, and safety data allows, the next group will be initiated in the same fashion at a dose of 2200 mg. If this dose is tolerated by subjects, and safety data allows, the next group will be initiated in the same fashion at a dose of 2600 mg. If this dose is tolerated by subjects, and safety data allows, the next group will be initiated in the same fashion at a dose of 3000 mg. Based upon safety data, the highest safely tolerated dose in Part 1 will be utilized as the supratherapeutic dose in Part 2.
- Conditions
- Qt Interval, Variation in
- Being tested
- WCK 2349, Placebo, Moxifloxacin
- Keywords
- TQT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCK 2349Drug
PlaceboDrug
MoxifloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo matched to WCK 2349, oral tablet(s)
Placebo matched to moxifloxacin overencapsulated tablet Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Moxifloxacin 400 mg positive control (overencapsulated tablet) Receives: Drug: Moxifloxacin |
| WCK 2349 | Experimental | WCK 2349 supratherapeutic dose determined in Part 1, oral tablet(s) Receives: Drug: WCK 2349 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QTc interval
Measured: Baseline and 48 hours
Secondary outcomes (2)
Highest dose of WCK 2349 tolerated
Measured: Baseline and 48 hours
Number of Adverse Events
Measured: Baseline and 7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Qt Interval, Variation inStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217930
- Sponsor's protocol ID
- W-2349-101
- Status last verified
- Oct 2015
- First submitted
- 31 Jul 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. 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 2349 on the QT/QTc Interval in Health Volunteers
- ClinicalTrials.gov ID
- NCT02217930
- Acronym / sponsor ID
- W-2349-101
- Conditions
- Qt Interval, Variation in
- Keywords
- TQT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- 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 study designed to determine the effect induced by WCK 2349 on the QT interval.
The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2) to assess the safety of high doses of single-dose administration of WCK 2349 on the QT interval.
Detailed description
Part 1 of this study will determine the supratherapeutic dose to be used in Part 2. Part 1will enroll 8 subjects at each of 4 dose levels (up to 32 subjects). Cohorts will be staggered so that appropriate safety monitoring and follow-up can be performed for each subject at each dose level.
Safety monitoring will be based upon review of AEs, ECGs and clinical laboratory test results prior to escalation to the next dose level.
At the first dose level, 6 subjects will be randomly assigned to receive a single dose of WCK 2349 at 1800 mg and 2 subjects will be randomly assigned to placebo. If this dose is tolerated by subjects, and safety data allows, the next group will be initiated in the same fashion at a dose of 2200 mg. If this dose is tolerated by subjects, and safety data allows, the next group will be initiated in the same fashion at a dose of 2600 mg. If this dose is tolerated by subjects, and safety data allows, the next group will be initiated in the same fashion at a dose of 3000 mg. Based upon safety data, the highest safely tolerated dose in Part 1 will be utilized as the supratherapeutic dose in Part 2.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matched to WCK 2349, oral tablet(s) Placebo matched to moxifloxacin overencapsulated tablet |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin 400 mg positive control (overencapsulated tablet) |
| WCK 2349 | Experimental | Drug: WCK 2349WCK 2349 supratherapeutic dose determined in Part 1, oral tablet(s) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subject between 18 and 55 years of age,inclusive, with a body mass index ≥18 to ≤33 kg/m2.
- Female subjects must be at least 2 years postmenopausal,surgically sterile, or practicing 2 highly effective methods of birth control (determined by the investigator or designee; one of the methods must be a barrier technique), not pregnant or lactating, and have a negative serum pregnancy test before enrolling in the study.
- Male or female subjects must agree to practice 2 highly effective methods of birth control (as determined by the investigator or designee; one of the methods must be a barrier technique) from Screening until 30 days after the last dose of study drug.
- Stable health based on no clinically significant findings on the medical history, physical examination, or clinical laboratory test results (as determined and documented by the investigator).
- Willing to comply with all study activities and procedures and provides written informed consent prior to any study procedures.
Key exclusion criteria (7 listed)
- An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval >110 milliseconds (msec); QT interval corrected by Fridericia's formula (QTcF) >430 msec (males) and >450 msec (females); PR interval >200 msec; heart rate (HR) <45 bpm; or any rhythm other than sinus rhythm that is interpreted by the investigator to be clinically significant.
- 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, hypercalcemia, or hypomagnesemia. Subjects will also be excluded if there is a family history of long QT syndrome or Brugada syndrome.
- 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). Blood pressure may be retested once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 2 assessments, and the subject may not be randomized.
- A resting HR of <40 beats per minute or >100 beats per minute when vital signs are measured at Screening or Check-in (Day -1).
- Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
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 2349 | Drug | WCK 2349 |
| Placebo | Drug | Placebo |
| Moxifloxacin | Drug | Moxifloxacin |
Primary outcome
Change in QTc interval
Time frame: Baseline and 48 hours
2 secondary outcomes
Highest dose of WCK 2349 tolerated
Time frame: Baseline and 48 hours
Number of Adverse Events
Time frame: Baseline and 7 days after the last 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 29 Oct 2015.
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.
Carlos Sanabria, MD principal investigator
Spaulding Clinical Research Inc.
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 2349 and Moxifloxacin in people with Qt Interval, Variation in, 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 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 29 Oct 2015. 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 in QTc interval (time frame: Baseline and 48 hours). 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 29 Oct 2015.