Trial Outcomes & Findings for Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers (NCT NCT03012828)
NCT ID: NCT03012828
Last Updated: 2019-03-14
Results Overview
Triplicate 10-second ECG recordings taken 1 minute apart using a Mortara continuous 12-lead digital ECG recorder connected to each subject during the Baseline to 72-hour post dose confinement period. Baseline only and baseline and placebo adjusted changes in QTc interval (corrected using the Friderica formula, QTcF) at each timepoint for each dose level were determined. The mean change from baseline (without and with placebo correction, dQTcF and ddQTcF respectively) at each of the 14 time points was calculated for each dose level. The primary outcome measure was the mean dQTcF for all subjects(the dQTcF gradient). The mean dQTcF for each active treatment group was determined at each post dose timepoint but the mean dQTcF by dose level was not calculated. The mean dQTcF at approximate moxidectin Tmax (hour 3 or hour 4) for each active treatment group and at hour 3 for the placebo group is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Baseline (pre-dose) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, and 72 hours post dosing
Results posted on
2019-03-14
Participant Flow
Participant milestones
| Measure |
Moxidectin 4mg
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
10 subjects will receive a single oral dose of placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
8
|
10
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Moxidectin 4mg
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
10 subjects will receive a single oral dose of placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Non-compliance with protocol
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Delay to last visit would delay DBL
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Moxidectin 4mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
n=10 Participants
10 subjects will receive a single oral dose of placebo
Placebo
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 8.73 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 8.27 • n=4 Participants
|
30.2 years
STANDARD_DEVIATION 8.87 • n=21 Participants
|
32.3 years
STANDARD_DEVIATION 6.72 • n=8 Participants
|
32.0 years
STANDARD_DEVIATION 8.15 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
10 participants
n=8 Participants
|
60 participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
26.2 kilogram /meter squared (kg/m2)
STANDARD_DEVIATION 3.74 • n=5 Participants
|
24.9 kilogram /meter squared (kg/m2)
STANDARD_DEVIATION 3.35 • n=7 Participants
|
25.8 kilogram /meter squared (kg/m2)
STANDARD_DEVIATION 3.71 • n=5 Participants
|
25.1 kilogram /meter squared (kg/m2)
STANDARD_DEVIATION 3.00 • n=4 Participants
|
26.7 kilogram /meter squared (kg/m2)
STANDARD_DEVIATION 3.09 • n=21 Participants
|
26.1 kilogram /meter squared (kg/m2)
STANDARD_DEVIATION 3.11 • n=8 Participants
|
25.8 kilogram /meter squared (kg/m2)
STANDARD_DEVIATION 3.26 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, and 72 hours post dosingPopulation: The ECG population included all subjects who received one dose of study drug and have at least 1 pair of pre-dose and post-dose QTc interval and was used in the model.
Triplicate 10-second ECG recordings taken 1 minute apart using a Mortara continuous 12-lead digital ECG recorder connected to each subject during the Baseline to 72-hour post dose confinement period. Baseline only and baseline and placebo adjusted changes in QTc interval (corrected using the Friderica formula, QTcF) at each timepoint for each dose level were determined. The mean change from baseline (without and with placebo correction, dQTcF and ddQTcF respectively) at each of the 14 time points was calculated for each dose level. The primary outcome measure was the mean dQTcF for all subjects(the dQTcF gradient). The mean dQTcF for each active treatment group was determined at each post dose timepoint but the mean dQTcF by dose level was not calculated. The mean dQTcF at approximate moxidectin Tmax (hour 3 or hour 4) for each active treatment group and at hour 3 for the placebo group is reported.
Outcome measures
| Measure |
Moxidectin 4mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
n=10 Participants
10 subjects will receive a single oral dose of placebo
Placebo
|
All Subjects
n=60 Participants
50 subjects received a single dose of between 4mg and 36mg of moxidectin. 10 subjects received a dose of placebo,
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in QTc Interval (Corrected by Friderica's Formula, dQTcF) Associated With Plasma Moxidectin Concentrations After a Single Dose
|
-5.1 millseconds
Interval -10.9 to 0.68
|
-4.5 millseconds
Interval -9.19 to 0.27
|
-4.5 millseconds
Interval -8.39 to -0.63
|
-6.3 millseconds
Interval -12.68 to 0.04
|
-3.9 millseconds
Interval -7.77 to 0.03
|
-2.9 millseconds
Interval -6.58 to 0.76
|
-0.0077 millseconds
Interval -0.0255 to 0.0101
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12*, 24, 36, 48, 60, and 72 hours and days 8,15 and 22 post dosingPopulation: Pharmacokinetic population - includes all subjects who received at least 1 dose of moxidectin and provide an adequate number of plasma samples for determination of PK parameters, analyzed according to drug received.
Concentrations of moxidectin in plasma were assessed by collection of plasma samples at pre-specified intervals after oral dosing with moxidectin. The concentration of moxidectin was determined using a validated LC MS/MS method.The pharmacokinetic time points coincided with ECG collection timepoints (within 5 minutes and no later than 10 minutes after ECG recordings). Plasma PK parameters were estimated from the concentration measurements, including maximum concentration (Cmax) for each individual and mean for each dose cohort.
Outcome measures
| Measure |
Moxidectin 4mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
10 subjects will receive a single oral dose of placebo
Placebo
|
All Subjects
50 subjects received a single dose of between 4mg and 36mg of moxidectin. 10 subjects received a dose of placebo,
|
|---|---|---|---|---|---|---|---|
|
Concentrations of Moxidectin in Plasma
|
27.2 nanogram/milliliter
Geometric Coefficient of Variation 30.6
|
56.7 nanogram/milliliter
Geometric Coefficient of Variation 20.8
|
133 nanogram/milliliter
Geometric Coefficient of Variation 27.1
|
176 nanogram/milliliter
Geometric Coefficient of Variation 18.7
|
247 nanogram/milliliter
Geometric Coefficient of Variation 19.7
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Baseline and Days 1, 2, 3, 4, 22 and Week 12Population: Safety population - all who received at least one dose of study drug
Changes from baseline in QTcF exceeding regulatory standard categorical limits (\> 30msec change or exceeding 450msec). Report applies to changes of 30msec - \</= 60msec only
Outcome measures
| Measure |
Moxidectin 4mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
n=10 Participants
10 subjects will receive a single oral dose of placebo
Placebo
|
All Subjects
50 subjects received a single dose of between 4mg and 36mg of moxidectin. 10 subjects received a dose of placebo,
|
|---|---|---|---|---|---|---|---|
|
Subjects With Categorical Changes From Baseline in 12-lead Electrocardiograms (ECGs)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-dose) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, and 72 hours post dosingPopulation: ECG population - all subjects who receive one dose of study drug and have at least one pair of pre-dose and post-dose QTc data, analyzed as randomized
Changes from Baseline were assessed at each timepoint up to 72 hours post dose. Mean changes across the 72 hour assessment period for each parameter were calculated for each moxidectin group and the placebo group and for the population overall.
Outcome measures
| Measure |
Moxidectin 4mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
n=10 Participants
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
n=10 Participants
10 subjects will receive a single oral dose of placebo
Placebo
|
All Subjects
n=60 Participants
50 subjects received a single dose of between 4mg and 36mg of moxidectin. 10 subjects received a dose of placebo,
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate (HR) and Duration of Other Interval Parameters (PR and QRS)
Change in Heart rate (HR)
|
-1.0 milliseconds
Interval -4.8 to 2.76
|
0.5 milliseconds
Interval -2.79 to 3.85
|
-1.1 milliseconds
Interval -6.35 to 4.07
|
-3.6 milliseconds
Interval -10.93 to 3.65
|
-1.5 milliseconds
Interval -7.34 to 4.42
|
-2.9 milliseconds
Interval -6.21 to 0.39
|
-0.005 milliseconds
Interval -0.018 to 0.009
|
|
Change From Baseline in Heart Rate (HR) and Duration of Other Interval Parameters (PR and QRS)
Change in PR interval
|
2.2 milliseconds
Interval -0.49 to 4.87
|
-0.1 milliseconds
Interval -5.84 to 5.66
|
-2.1 milliseconds
Interval -7.63 to 3.47
|
4.6 milliseconds
Interval -3.1 to 12.34
|
-3.5 milliseconds
Interval -8.86 to 1.92
|
-1.8 milliseconds
Interval -5.64 to 1.98
|
-0.002 milliseconds
Interval -0.016 to 0.012
|
|
Change From Baseline in Heart Rate (HR) and Duration of Other Interval Parameters (PR and QRS)
Change in QRS interval
|
-1.6 milliseconds
Interval -3.26 to 0.1
|
-0.7 milliseconds
Interval -5.38 to 3.94
|
0.4 milliseconds
Interval -1.75 to 2.49
|
-0.8 milliseconds
Interval -3.55 to 2.03
|
0.4 milliseconds
Interval -2.0 to 2.86
|
1.2 milliseconds
Interval -0.29 to 2.59
|
0.004 milliseconds
Interval -0.003 to 0.012
|
Adverse Events
Moxidectin 4mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moxidectin 8mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moxidectin 16mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Moxidectin 24mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moxidectin 36mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moxidectin 4mg
n=10 participants at risk
10 subjects will receive a single oral dose of moxidectin 4mg
Moxidectin
|
Moxidectin 8mg
n=10 participants at risk
10 subjects will receive a single oral dose of moxidectin 8mg
Moxidectin
|
Moxidectin 16mg
n=10 participants at risk
10 subjects will receive a single oral dose of moxidectin 16mg
Moxidectin
|
Moxidectin 24mg
n=10 participants at risk
10 subjects will receive a single oral dose of moxidectin 24mg
Moxidectin
|
Moxidectin 36mg
n=10 participants at risk
10 subjects will receive a single oral dose of moxidectin 36mg
Moxidectin
|
Placebo
n=10 participants at risk
10 subjects will receive a single oral dose of placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
General disorders
Medical device site reaction
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Investigations
AST increased
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Investigations
Blood cholesterol increased
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the full 12 weeks of study follow-up
|
0.00%
0/10 • Adverse events were collected over the full 12 weeks of study follow-up
|
Additional Information
Sally Kinrade, Vice President (Clinical Development)
Medicines Development Limited
Phone: +613 9629 6111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place