Status:
COMPLETED
Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers
Lead Sponsor:
Wockhardt
Conditions:
Qt Interval, Variation in
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
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 appropr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02217930
Start Date
August 1 2014
End Date
July 1 2015
Last Update
October 29 2015
Active Locations (1)
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1
Phase 1 unit : Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095