Back to resultsStudy to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Primary Purpose
Pediculosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ha44
Ha44 Placebo
Moxifloxacin Placebo
Moxifloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis
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)
Sites / Locations
- Spaulding Clinical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
HA44 Abametapir Lotion
Placebo
Moxifloxacin
Arm Description
Study drug plus positive-control placebo.
Placebo plus positive-control placebo.
Placebo plus positive control
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01518699
First Posted
January 17, 2012
Last Updated
July 8, 2021
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01518699
Brief Title
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HA44 Abametapir Lotion
Arm Type
Experimental
Arm Description
Study drug plus positive-control placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo plus positive-control placebo.
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Placebo plus positive control
Intervention Type
Drug
Intervention Name(s)
Ha44
Other Intervention Name(s)
Abametapir Lotion
Intervention Description
Abametapir Lotion 0.74%
Intervention Type
Drug
Intervention Name(s)
Ha44 Placebo
Other Intervention Name(s)
Abametapir Placebo
Intervention Description
Ha44 Vehicle Gel without Abametapir
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Placebo
Intervention Description
Moxifloxacin Placebo
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Moxifloxacin Active
Intervention Description
Moxifloxacin 400mg
Primary Outcome Measure Information:
Title
Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF
Description
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
Time Frame
36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Dietz, MD
Organizational Affiliation
Spaulding Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Clinical
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
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