Pediculosis
Conditions
Brief summary
The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.
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).
Interventions
DRUGHa44
Abametapir Lotion 0.74%
DRUGHa44 Placebo
Ha44 Vehicle Gel without Abametapir
DRUGMoxifloxacin Placebo
Moxifloxacin Placebo
DRUGMoxifloxacin
Moxifloxacin 400mg
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-dummy technique was used to mask the treatments. The test product is a gel and the positive control is a tablet. The active test product was administered with placebo positive control, while the active positive control was administered with placebo test product. The placebo group received both placebos.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF | 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 |
Countries
United States
Participant flow
Recruitment details
Fifty seven (57) subjects were enrolled into the study. Of them 53 completed all 3 periods of the study.
Pre-assignment details
The subjects were divided into 6 intervention arms with sequences ABC, ACB, BAC, BCA, CAB and CBA, where A is HA 44 (Abametapir) gel + Moxifloxacin placebo; B is HA 44 placebo + Moxifloxacin placebo and C is Moxifloxacin 400 mg tablet + HA 44 placebo.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Sequence ABC The subjects received sequence ABC in the three periods with a 4 day washout in between the periods. In each treatment period, subjects received a single dose of the treatment as follows:
In period 1 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.
In period 2 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.
in period 3 they received Moxifloxacin 400 mg tablet + HA 44 placebo. | 10 |
| Treatment Sequence ACB The subjects received sequence ACB in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:
In period 1 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.
In period 2 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.
in period 3 they received HA 44 placebo + Moxifloxacin placebo. | 9 |
| Treatment Sequence BAC The subjects received sequence BAC in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:
In period 1 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.
In period 2 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.
In period 3 they received Moxifloxacin 400 mg tablet + HA 44 placebo. | 9 |
| Treatment Sequence BCA The subjects received sequence BCA in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:
In period 1 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.
In period 2 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.
In period 3 they received HA 44 gel + Moxifloxacin placebo tablet. | 10 |
| Treatment Sequence CAB The subjects received sequence CAB in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:
In period 1 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.
In period 2 they received HA 44 gel + Moxifloxacin placebo tablet, followed by a 4 day washout period.
In period 3 they received HA 44 placebo + Moxifloxacin placebo. | 10 |
| Treatment Sequence CBA The subjects received sequence CBA in the three periods with a 4 day washout in between two periods. In each treatment period subjects received a single dose of the treatment as follows:
In period 1 they received Moxifloxacin 400 mg tablet + HA 44 placebo, followed by a 4 day washout period.
In period 2 they received HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period.
In period 3 they received HA 44 gel + Moxifloxacin placebo tablet. | 9 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 2 | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
| Period 2 | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 2 | Protocol Violation | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Treatment Sequence ACB | Total | Treatment Sequence ABC | Treatment Sequence CBA | Treatment Sequence CAB | Treatment Sequence BCA | Treatment Sequence BAC |
|---|---|---|---|---|---|---|---|
| Age, Customized | 28.0 years STANDARD_DEVIATION 9.04 | 29.9 years STANDARD_DEVIATION 7.92 | 28.1 years STANDARD_DEVIATION 5.47 | 33.8 years STANDARD_DEVIATION 8.66 | 32.6 years STANDARD_DEVIATION 9.7 | 28.2 years STANDARD_DEVIATION 6.81 | 28.8 years STANDARD_DEVIATION 7.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 9 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 48 Participants | 8 Participants | 8 Participants | 9 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 22 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 32 Participants | 7 Participants | 6 Participants | 8 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 9 participants | 57 participants | 10 participants | 9 participants | 10 participants | 10 participants | 9 participants |
| Sex: Female, Male Female | 6 Participants | 31 Participants | 3 Participants | 6 Participants | 5 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 26 Participants | 7 Participants | 3 Participants | 5 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 54 | 0 / 53 |
| other Total, other adverse events | 26 / 57 | 3 / 54 | 14 / 53 |
| serious Total, serious adverse events | 0 / 57 | 0 / 54 | 0 / 53 |
Outcome results
Primary
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
Time frame: 36 hours
Population: All completed subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HA 44 Gel + Moxifloxacin Placebo | Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF | -9.7 milliseconds | Standard Deviation 10.27 |
| HA 44 Placebo + Moxifloxacin Placebo | Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF | -9.2 milliseconds | Standard Deviation 10.1 |
| Moxifloxacin 400 mg Tablet +HA 44 Placebo | Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF | 6.1 milliseconds | Standard Deviation 7.64 |