PediculosisPhase 1NCT01518699

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

A Phase 1 study testing Ha44 and Moxifloxacin in people with Pediculosis, run by Dr. Reddy's Laboratories Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Pediculosis
What is being tested?: Ha44 and Moxifloxacin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Jan 2012to May 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Clinical
West Bend, Wisconsin, 53095

Other trials in United States

About this study

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

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

Read the 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).

Conditions: Pediculosis
Being tested: Ha44, Ha44 Placebo, Moxifloxacin Placebo, Moxifloxacin
Medical subject headings: Lice Infestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ha44Drug
Also called Abametapir Lotion
Abametapir Lotion 0.74%
Ha44 PlaceboDrug
Also called Abametapir Placebo
Ha44 Vehicle Gel without Abametapir
Moxifloxacin PlaceboDrug
Moxifloxacin Placebo
MoxifloxacinDrug
Also called Moxifloxacin Active
Moxifloxacin 400mg

Study groups in NCT01518699
Study group	Role	What they receive
HA44 Abametapir Lotion	Experimental	Study drug plus positive-control placebo. Receives: Drug: Ha44; Drug: Moxifloxacin Placebo
Placebo	Placebo comparator	Placebo plus positive-control placebo. Receives: Drug: Ha44 Placebo; Drug: Moxifloxacin Placebo
Moxifloxacin	Active comparator	Placebo plus positive control Receives: Drug: Ha44 Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012May 2012

First posted26 Jan 2012 (estimated)
Study startJan 2012
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PediculosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01518699
Sponsor's protocol ID: Ha02-005
Status last verified: Jul 2021
First submitted: 17 Jan 2012
Last updated: 9 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pediculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01518699
Acronym / sponsor ID: Ha02-005
Conditions: Pediculosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 26 Jan 2012 (estimated)
Results: Posted 9 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
HA44 Abametapir Lotion	Experimental	Drug: Ha44, Drug: Moxifloxacin PlaceboStudy drug plus positive-control placebo.
Placebo	Placebo comparator	Drug: Ha44 Placebo, Drug: Moxifloxacin PlaceboPlacebo plus positive-control placebo.
Moxifloxacin	Active comparator	Drug: Ha44 Placebo, Drug: MoxifloxacinPlacebo plus positive control

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ha44Also: Abametapir LotionAbametapir Lotion 0.74%	Drug	HA44 Abametapir Lotion
Ha44 PlaceboAlso: Abametapir PlaceboHa44 Vehicle Gel without Abametapir	Drug	Moxifloxacin, Placebo
Moxifloxacin PlaceboMoxifloxacin Placebo	Drug	HA44 Abametapir Lotion, Placebo
MoxifloxacinAlso: Moxifloxacin ActiveMoxifloxacin 400mg	Drug	Moxifloxacin

Primary outcome

Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF
Time frame: 36 hours
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

Results and safety

Results posted to the registry on 9 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence ABC	10	10
Treatment Sequence ACB	9	9
Treatment Sequence BAC	9	9
Treatment Sequence BCA	10	10
Treatment Sequence CAB	10	10
Treatment Sequence CBA	9	9

Primary outcome: Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF

Time frame: 36 hours. Mean (Standard Deviation). Unit: milliseconds

Measure	HA 44 Gel + Moxifloxacin Placebo n = 53	HA 44 Placebo + Moxifloxacin Placebo n = 53	Moxifloxacin 400 mg Tablet +HA 44 Placebo n = 53
Value	-9.7 (10.27)	-9.2 (10.10)	6.1 (7.64)

Population analysed: All completed subjects

Adverse events

Time frame: Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HA44 Abametapir Lotion	0 of 57 (0%)	26 of 57 (45.6%)	0 of 57
Placebo	0 of 54 (0%)	3 of 54 (5.6%)	0 of 54
Moxifloxacin	0 of 53 (0%)	14 of 53 (26.4%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pediculosis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Albert Dietz, MD principal investigator

Spaulding Clinical

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ha44 and Moxifloxacin in people with Pediculosis, run by Dr. Reddy's Laboratories Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF (time frame: 36 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01518699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.