Status:
COMPLETED
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Pediculosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.
Detailed Description
This study was a randomized, double-blind, placebo- and active-controlled, crossover study that evaluated the potential of Abametapir to prolong cardiac repolarization in healthy adult subjects (total...
Eligibility Criteria
Inclusion
- 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
- 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 (non-cutaneous) infection within 1 week before clinic admission
- supine mean systolic blood pressure \<90 or \>140 mmHg and a mean diastolic blood pressure \<50 or \>90 mmHg
- positive for HIV or hepatitis C antibody or hepatitis B antigen (HBsAg)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01518699
Start Date
January 1 2012
End Date
May 1 2012
Last Update
July 9 2021
Active Locations (1)
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1
Spaulding Clinical
West Bend, Wisconsin, United States, 53095