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The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA44 Abametapir Lotion | Experimental | Study drug plus positive-control placebo. |
|
| Placebo | Placebo Comparator | Placebo plus positive-control placebo. |
|
| Moxifloxacin | Active Comparator | Placebo plus positive control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ha44 | Drug | Abametapir Lotion 0.74% |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Dietz, MD | Spaulding Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical | West Bend | Wisconsin | 53095 | United States |
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.
Fifty seven (57) subjects were enrolled into the study. Of them 53 completed all 3 periods of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence ABC | The subjects received sequence ABC 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 HA 44 placebo + Moxifloxacin placebo, followed by a 4 day washout period. in period 3 they received Moxifloxacin 400 mg tablet + HA 44 placebo. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
All randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All completed subjects | Posted | Mean | Standard Deviation | milliseconds | 36 hours |
|
Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HA44 Abametapir Lotion | Study drug plus positive-control placebo. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Srinivas Sidgiddi | Dr. Reddy's Laboratories Inc. | 9084585362 | srinivassidgiddi@drreddys.com |
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| ID | Term |
|---|---|
| D010373 | Lice Infestations |
| ID | Term |
|---|---|
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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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.
| Ha44 Placebo | Drug | Ha44 Vehicle Gel without Abametapir |
|
|
| Moxifloxacin Placebo | Drug | Moxifloxacin Placebo |
|
| Moxifloxacin | Drug | Moxifloxacin 400mg |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The maximal difference between baseline and post treatment value in QTcF
| OG002 | Moxifloxacin 400 mg Tablet +HA 44 Placebo | The maximum difference between baseline and post treatment values in QTcF |
|
|
| 57 |
| 0 |
| 57 |
| 26 |
| 57 |
| EG001 | Placebo | Placebo plus positive-control placebo. | 0 | 54 | 0 | 54 | 3 | 54 |
| EG002 | Moxifloxacin | Placebo plus Moxifloxacin | 0 | 53 | 0 | 53 | 14 | 53 |
| Application site pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Application site pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
|
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| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |