Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers (NCT01518699) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
United States57 participantsStarted 2012-01
Plain-language summary
The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* healthy male or female subject, 18 to 50 years of age, inclusive, at least 45 kg and has a body mass index (BMI) of 18 to 33 kg/m2,
* Female subjects of childbearing potential must not be pregnant and not lactating or prepared to practice highly effective birth control methods
* The subject has normal 12-lead ECG results or, if abnormal, the abnormality is not clinically significant (as determined by the investigator).
Exclusion Criteria:
* has evidence of cardiac conduction abnormalities
* history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative due to cardiac causes at a young age
* potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal
* laboratory test results at Screening are \>2 x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), \>1.5 x ULN for bilirubin, or \>1.5 x ULN for creatinine
* history or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
* febrile illness or symptomatic viral, bacterial (including upper respiratory infection), or fungal (n…
What they're measuring
1
Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF