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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hatchtech Pty Ltd
ClinicalTrials.gov Identifier:
NCT01518699
First received: January 17, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Pediculosis
Drug: Ha44
Drug: Ha44 Placebo
Drug: Moxifloxacin Placebo
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Male and Female Adult Subjects, Preceded by a Dose-Escalation Study to Determine the Supratherapeutic Dose of Ha44

Resource links provided by NLM:


Further study details as provided by Hatchtech Pty Ltd:

Primary Outcome Measures:
  • Part 1: safety and tolerability of single applications of Ha44 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    safety and tolerability of single applications of Ha44 of increasing exposure duration assessed by the following measures: AEs, application site reactions, blood pressure and other vital sign measurements, 12 lead ECGs, incidence and magnitude of clinically significant changes from baseline in clinical laboratory values (hematology, chemistry, and urinalysis), and physical examinations.

  • Part 2: difference between the post-dose time matched baseline adjusted mean QTcF (Ha44 0.74% Gel) and the post dose time-matched baseline adjusted mean QTcF (placebo) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary endpoint for Part 2 is the difference between the post-dose time matched baseline adjusted mean QTcF (Ha44 0.74% Gel) and the post dose time-matched baseline adjusted mean QTcF (placebo) = [ΔQTcF (Ha44 0.74% Gel) - ΔQTcF (placebo)] = ΔΔQTcF.


Secondary Outcome Measures:
  • Part 1: PK parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    PK parameters: Cmax, Tmax area under the curve from time zero to the last quantifiable sample AUClast) and also extrapolated to infinity (AUCinf), and the terminal-phase rate constant and half life (t½).

  • Part 2: The effect of Ha44 0.74% Gel compared to placebo on cardiac parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Part 2: The effect of Ha44 0.74% Gel compared to placebo on QTcB, heart rate, PR interval, RR interval, QRS interval, uncorrected QT interval, change in ST and T-wave morphology, categorical change in QTc variables, and correlation between the QTcF change from baseline and plasma concentrations.


Enrollment: 81
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part 1 Group 1
Low dose study drug in 6 of 8 subjects Placebo in 2 of 8 subjects
Drug: Ha44
study drug at low, moderate and high dose single exposure
Drug: Ha44 Placebo
Ha44 Vehicle Gel without Ha44
Part 1 Group 2
Mid dose study drug in 6 of 8 subjects Placebo in 2 of 8 subjects
Drug: Ha44
study drug at low, moderate and high dose single exposure
Drug: Ha44 Placebo
Ha44 Vehicle Gel without Ha44
Part 1 Group 3
High dose study drug in 6 or 8 subjects Placebo in 2 of 8 subjects
Drug: Ha44
study drug at low, moderate and high dose single exposure
Drug: Ha44 Placebo
Ha44 Vehicle Gel without Ha44
Part 2 Group A
Study drug plus positive-control placebo
Drug: Ha44
study drug at low, moderate and high dose single exposure
Drug: Moxifloxacin Placebo
Moxifloxacin Placebo
Part 2 Group B
Placebo plus positive-control placebo
Drug: Moxifloxacin Placebo
Moxifloxacin Placebo
Part 2 Group C
Placebo plus positive control
Drug: Moxifloxacin
moxifloxacin 400mg

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518699

Locations
United States, Wisconsin
Spaulding Clinical
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Hatchtech Pty Ltd
Investigators
Principal Investigator: Albert Dietz, MD Spaulding Clinical
  More Information

No publications provided

Responsible Party: Hatchtech Pty Ltd
ClinicalTrials.gov Identifier: NCT01518699     History of Changes
Other Study ID Numbers: Ha02-005
Study First Received: January 17, 2012
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014