Title
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Effect of Ha44 Gel on the ECG in Healthy Adult Subjects
Phase
Phase 1Lead Sponsor
Hatchtech Pty LtdStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
PediculosisIntervention/Treatment
abametapir moxifloxacin ...Study Participants
57The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.
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).
Abametapir Lotion 0.74%
Ha44 Vehicle Gel without Abametapir
Moxifloxacin Placebo
Moxifloxacin 400mg
Study drug plus positive-control placebo.
Placebo plus positive-control placebo.
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)
| Event Type | Organ System | Event Term | HA44 Abametapir Lotion | Placebo | Moxifloxacin |
|---|
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
