Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Pediculosis

In brief

The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.

Key facts

Study ID

NCT01518699

Run by

Dr. Reddy's Laboratories Limited

People needed

57

Starts

2012-01-01

Expected to finish

2012-05-01

Last updated by the study team

2021-07-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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)

Where it is running

• Spaulding Clinical — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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