Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Condition: Pediculosis
MeSH terms: Lice Infestations
Intervention: Ha44; Ha44 Placebo; Moxifloxacin Placebo; Moxifloxacin
Intervention description: Abametapir Lotion 0.74%; Ha44 Vehicle Gel without Abametapir; Moxifloxacin Placebo; Moxifloxacin 400mg
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-dummy technique was used to mask the treatments. The test product is a gel and the positive control is a tablet. The active test product was administered with placebo positive control, while the active positive control was administered with placebo test product. The placebo group received both placebos.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

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

Eligibility criteria:

        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)