Trial record 15 of 1818 for:
electrocardiogram
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
This study is ongoing, but not recruiting participants.
Sponsor:
Hatchtech Pty Ltd
Information provided by (Responsible Party):
Hatchtech Pty Ltd
ClinicalTrials.gov Identifier:
NCT01518699
First received: January 17, 2012
Last updated: July 9, 2012
Last verified: July 2012
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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.
| Estimated Enrollment: | 81 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2012 |
| Primary Completion Date: | April 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 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 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lice Infestations Ectoparasitic Infestations Skin Diseases, Parasitic Parasitic Diseases Skin Diseases, Infectious Skin Diseases Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013