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

Pediculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518699
• Other study ID #: Ha02-005
• Status: Completed
• Phase: Phase 1
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: July 2021
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lice Infestations
• Pediculosis

Intervention

Drug:
• Ha44
Abametapir Lotion 0.74%
• Ha44 Placebo
Ha44 Vehicle Gel without Abametapir
• Moxifloxacin Placebo
Moxifloxacin Placebo
• Moxifloxacin
Moxifloxacin 400mg

Locations

Country	Name	City	State
United States	Spaulding Clinical	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 = [?QTcF (Ha44 0.74% Gel) - ?QTcF (placebo)] = ??QTcF. This was compared with the difference between Moxifloxacin and placebo for time matched baseline adjusted mean QTcF = [?QTcF (Moxifloxacin) - ?QTcF (placebo)] = ??QTcF	36 hours