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

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

Detailed Description
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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 of 57 subjects).

Official Title
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A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Effect of Ha44 Gel on the ECG in Healthy Adult Subjects

Conditions
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Pediculosis

Intervention / Treatment
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* Drug: Ha44
* Drug: Ha44 Placebo
* Drug: Moxifloxacin Placebo
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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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 (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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA44 Abametapir Lotion<br>Study drug plus positive-control placebo. | Drug: Ha44<br>* Abametapir Lotion 0.74%<br>* Other names: Abametapir Lotion;Drug: Moxifloxacin Placebo<br>* Moxifloxacin Placebo<br>|
| Placebo Comparator: Placebo<br>Placebo plus positive-control placebo. | Drug: Ha44 Placebo<br>* Ha44 Vehicle Gel without Abametapir<br>* Other names: Abametapir Placebo;Drug: Moxifloxacin Placebo<br>* Moxifloxacin Placebo<br>|
| Active Comparator: Moxifloxacin<br>Placebo plus positive control | Drug: Ha44 Placebo<br>* Ha44 Vehicle Gel without Abametapir<br>* Other names: Abametapir Placebo;Drug: Moxifloxacin<br>* Moxifloxacin 400mg<br>* Other names: Moxifloxacin Active;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF | The primary endpoint is the difference between the active (HA44) and placebo for time matched baseline adjusted mean QTcF = [ΔQTcF (Ha44 0.74% Gel) - ΔQTcF (placebo)] = ΔΔQTcF. This was compared with the difference between Moxifloxacin and placebo for time matched baseline adjusted mean QTcF = [ΔQTcF (Moxifloxacin) - ΔQTcF (placebo)] = ΔΔQTcF | 36 hours |