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

Phase 1

Completed

• Conditions: Pediculosis
• Interventions: Drug: Ha44; Drug: Ha44 Placebo; Drug: Moxifloxacin Placebo; Drug: Moxifloxacin

• Registration Number: NCT01518699
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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 of 57 subjects).

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2021-05-16
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Results First Posted: 2021-07-09
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HA44 Abametapir Lotion	Ha44	Study drug plus positive-control placebo.
HA44 Abametapir Lotion	Moxifloxacin Placebo	Study drug plus positive-control placebo.
Placebo	Ha44 Placebo	Placebo plus positive-control placebo.
Placebo	Moxifloxacin Placebo	Placebo plus positive-control placebo.
Moxifloxacin	Ha44 Placebo	Placebo plus positive control
Moxifloxacin	Moxifloxacin	Placebo plus positive control

Primary Outcome Measures

Name	Time	Method
Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF	36 hours	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

Trial Locations

Locations (1)

Spaulding Clinical; 🇺🇸 West Bend, Wisconsin, United States