Trial Outcomes & Findings for Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers (NCT NCT01518699)
NCT ID: NCT01518699
Last Updated: 2021-07-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
36 hours
Results posted on
2021-07-09
Participant Flow
Fifty seven (57) subjects were enrolled into the study. Of them 53 completed all 3 periods of the study.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
10
|
9
|
9
|
10
|
10
|
9
|
|
Period 1
COMPLETED
|
10
|
9
|
9
|
10
|
10
|
9
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
10
|
9
|
9
|
10
|
10
|
9
|
|
Period 2
COMPLETED
|
8
|
7
|
9
|
10
|
10
|
9
|
|
Period 2
NOT COMPLETED
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
8
|
7
|
9
|
10
|
10
|
9
|
|
Period 3
COMPLETED
|
8
|
7
|
9
|
10
|
10
|
9
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Period 2
Protocol Violation
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Treatment Sequence ABC
n=10 Participants
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.
|
Treatment Sequence ACB
n=9 Participants
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.
|
Treatment Sequence BAC
n=9 Participants
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.
|
Treatment Sequence BCA
n=10 Participants
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.
|
Treatment Sequence CAB
n=10 Participants
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.
|
Treatment Sequence CBA
n=9 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
|
28.1 years
STANDARD_DEVIATION 5.47 • n=99 Participants
|
28.0 years
STANDARD_DEVIATION 9.04 • n=107 Participants
|
28.8 years
STANDARD_DEVIATION 7.21 • n=206 Participants
|
28.2 years
STANDARD_DEVIATION 6.81 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 9.70 • n=31 Participants
|
33.8 years
STANDARD_DEVIATION 8.66 • n=30 Participants
|
29.9 years
STANDARD_DEVIATION 7.92 • n=3 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
31 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
48 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
22 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
32 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
10 participants
n=7 Participants
|
10 participants
n=31 Participants
|
9 participants
n=30 Participants
|
57 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 36 hoursPopulation: All completed subjects
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
Outcome measures
| Measure |
HA 44 Gel + Moxifloxacin Placebo
n=53 Participants
The maximal difference between baseline and post treatment value in QTcF
|
HA 44 Placebo + Moxifloxacin Placebo
n=53 Participants
The maximal difference between baseline and post treatment value in QTcF
|
Moxifloxacin 400 mg Tablet +HA 44 Placebo
n=53 Participants
The maximum difference between baseline and post treatment values in QTcF
|
|---|---|---|---|
|
Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF
|
-9.7 milliseconds
Standard Deviation 10.27
|
-9.2 milliseconds
Standard Deviation 10.10
|
6.1 milliseconds
Standard Deviation 7.64
|
Adverse Events
HA44 Abametapir Lotion
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HA44 Abametapir Lotion
n=57 participants at risk
Study drug plus positive-control placebo.
|
Placebo
n=54 participants at risk
Placebo plus positive-control placebo.
|
Moxifloxacin
n=53 participants at risk
Placebo plus Moxifloxacin
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site erythema
|
19.3%
11/57 • Number of events 11 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
0.00%
0/54 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
|
Skin and subcutaneous tissue disorders
Application site pain
|
5.3%
3/57 • Number of events 3 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
0.00%
0/54 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
0.00%
0/53 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/57 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
0.00%
0/54 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
9.4%
5/53 • Number of events 5 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
2/57 • Number of events 2 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
0.00%
0/54 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
7.5%
4/53 • Number of events 4 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
5.3%
3/57 • Number of events 3 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
0.00%
0/54 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
|
Nervous system disorders
Headache
|
10.5%
6/57 • Number of events 6 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
5.6%
3/54 • Number of events 3 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
9.4%
5/53 • Number of events 5 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.3%
3/57 • Number of events 3 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
0.00%
0/54 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded from the time of signing informed consent until the last study assessment i.e. for 18 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place