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

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ClinicalTrials.gov Identifier: NCT01518699
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
Hatchtech Pty Ltd

Tracking Information
First Submitted Date  ICMJE January 17, 2012
First Posted Date  ICMJE January 26, 2012
Last Update Posted Date July 23, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • Part 1: safety and tolerability of single applications of Ha44 [ Time Frame: 6 months ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01518699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • Part 1: PK parameters [ Time Frame: 6 months ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Pediculosis
Intervention  ICMJE
  • Drug: Ha44
    study drug at low, moderate and high dose single exposure
  • Drug: Ha44 Placebo
    Ha44 Vehicle Gel without Ha44
  • Drug: Moxifloxacin Placebo
    Moxifloxacin Placebo
  • Drug: Moxifloxacin
    moxifloxacin 400mg
Study Arms  ICMJE
  • Part 1 Group 1
    Low dose study drug in 6 of 8 subjects Placebo in 2 of 8 subjects
    Interventions:
    • Drug: Ha44
    • Drug: Ha44 Placebo
  • Part 1 Group 2
    Mid dose study drug in 6 of 8 subjects Placebo in 2 of 8 subjects
    Interventions:
    • Drug: Ha44
    • Drug: Ha44 Placebo
  • Part 1 Group 3
    High dose study drug in 6 or 8 subjects Placebo in 2 of 8 subjects
    Interventions:
    • Drug: Ha44
    • Drug: Ha44 Placebo
  • Part 2 Group A
    Study drug plus positive-control placebo
    Interventions:
    • Drug: Ha44
    • Drug: Moxifloxacin Placebo
  • Part 2 Group B
    Placebo plus positive-control placebo
    Intervention: Drug: Moxifloxacin Placebo
  • Part 2 Group C
    Placebo plus positive control
    Intervention: Drug: Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2012)
81
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01518699
Other Study ID Numbers  ICMJE Ha02-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hatchtech Pty Ltd
Study Sponsor  ICMJE Hatchtech Pty Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Albert Dietz, MD Spaulding Clinical
PRS Account Hatchtech Pty Ltd
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP