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

Dr.Reddy's Laboratories

Status and phase: Completed; Phase 1

Conditions: Pediculosis

Treatments: Drug: Ha44; Drug: Moxifloxacin Placebo; Drug: Moxifloxacin; Drug: Ha44 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518699

Ha02-005

Details and patient eligibility

About

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

Full 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).

Enrollment: 57 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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57 participants in 3 patient groups, including a placebo group

HA44 Abametapir Lotion

Experimental group

Description:

Study drug plus positive-control placebo.

Treatment:

Drug: Ha44

Drug: Moxifloxacin Placebo

Placebo

Placebo Comparator group

Description:

Placebo plus positive-control placebo.

Treatment:

Drug: Ha44 Placebo

Drug: Moxifloxacin Placebo

Moxifloxacin

Active Comparator group

Description:

Placebo plus positive control

Treatment:

Drug: Ha44 Placebo

Drug: Moxifloxacin