Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: QT/QTc Interval in Healthy Volunteers

In brief

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

Key facts

Study ID

NCT03554304

Run by

Wockhardt

People needed

60

Starts

2017-02-09

Expected to finish

2017-10-06

Last updated by the study team

2018-06-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Spaulding Clinical Research — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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