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

NCT01518699 | Completed Phase 1 Results

• 1 other identifier: Ha02-005
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediculosis

Outcome Measures

Primary Outcomes (1)

• 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

  36 hours

Study Arms (3)

HA44 Abametapir Lotion

EXPERIMENTAL

Study drug plus positive-control placebo.

Drug: Ha44; Drug: Moxifloxacin Placebo

Placebo

PLACEBO COMPARATOR

Placebo plus positive-control placebo.

Drug: Ha44 Placebo; Drug: Moxifloxacin Placebo

Moxifloxacin

ACTIVE COMPARATOR

Placebo plus positive control

Drug: Ha44 Placebo; Drug: Moxifloxacin

Interventions

Ha44 DRUG

Abametapir Lotion 0.74%

Also known as: Abametapir Lotion

HA44 Abametapir Lotion

Ha44 Placebo DRUG

Ha44 Vehicle Gel without Abametapir

Also known as: Abametapir Placebo

Moxifloxacin; Placebo

Moxifloxacin Placebo DRUG

Moxifloxacin Placebo

HA44 Abametapir Lotion; Placebo

Moxifloxacin DRUG

Moxifloxacin 400mg

Also known as: Moxifloxacin Active

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

Lice Infestations

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Srinivas Sidgiddi
• Organization: Dr. Reddy's Laboratories Inc.

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Albert Dietz, MD

  Spaulding Clinical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-07

Locations

US (1)