Trial Outcomes & Findings for Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus (NCT NCT01742208)
NCT ID: NCT01742208
Last Updated: 2020-02-12
Results Overview
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline, Day 3 to Day 27
Results posted on
2020-02-12
Participant Flow
The study was conducted at 7 sites in United States between 08 February 2013 and 13 January 2014. A total of 36 participants were enrolled and treated in the study which consisted of 2 groups: Pioneer Group and Expansion Groups.
In this study, first 3 participants (Pioneer Group) received open-label sotagliflozin. Once dosing was completed in Pioneer Group, 33 different participants were randomized in 1:1 ratio to Expansion groups (sotagliflozin or placebo). Randomization was stratified according to baseline glycosylated hemoglobin (A1C \[\<=8 percent {%} vs. \>8%\]).
Participant milestones
| Measure |
Sotagliflozin 400 mg - Pioneer Group
Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
17
|
16
|
|
Overall Study
COMPLETED
|
3
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=17 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=16 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Height
|
172.3 centimeter (cm)
STANDARD_DEVIATION 8.5 • n=5 Participants
|
170.5 centimeter (cm)
STANDARD_DEVIATION 11.7 • n=7 Participants
|
169.5 centimeter (cm)
STANDARD_DEVIATION 12.2 • n=5 Participants
|
170.2 centimeter (cm)
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 11.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
Weight
|
84.5 kilogram (kg)
STANDARD_DEVIATION 19.2 • n=5 Participants
|
76.8 kilogram (kg)
STANDARD_DEVIATION 15.5 • n=7 Participants
|
78.4 kilogram (kg)
STANDARD_DEVIATION 14.8 • n=5 Participants
|
78.1 kilogram (kg)
STANDARD_DEVIATION 15.1 • n=4 Participants
|
|
Insulin Therapy
Multiple Daily Injections (MDI)
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Insulin Therapy
Continuous Subcutaneous Insulin Infusion (CSII)
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 3 to Day 27Population: Analysis was performed using ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.
Outcome measures
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=17 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=15 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period)
|
-46.32 percent change
Interval -99.71 to 7.06
|
-7.00 percent change
Interval -19.18 to 5.17
|
-32.14 percent change
Interval -45.09 to -19.18
|
SECONDARY outcome
Timeframe: Baseline, Day 3 to Day 27Population: Analysis was performed using ITT population. Here, number analyzed=participants with available data for this outcome measure.
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\] / number of assessments)/baseline over Days 3 to 27. Percent change was calculated and is presented separately for each meal: i.e., breakfast, lunch and dinner. LS Means and CI for the Expansion groups were based on an ANCOVA model . LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.
Outcome measures
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=17 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=16 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period)
Before Breakfast
|
-42.19 percent change
Interval -169.85 to 85.46
|
10.79 percent change
Interval -13.28 to 34.86
|
-25.16 percent change
Interval -51.15 to 0.82
|
|
Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period)
Before Lunch
|
-59.02 percent change
Interval -109.11 to -8.93
|
3.94 percent change
Interval -19.33 to 27.2
|
-25.85 percent change
Interval -50.59 to -1.12
|
|
Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period)
Before Dinner
|
-34.83 percent change
Interval -129.08 to 59.42
|
33.34 percent change
Interval -6.53 to 73.22
|
-24.02 percent change
Interval -66.57 to 18.54
|
SECONDARY outcome
Timeframe: Baseline, Day 3 to Day 27Population: Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/ number of assessments)/baseline over Days 3 to 27. LS Means and CI for the Expansion groups were based on an ANCOVA model. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.
Outcome measures
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=17 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=15 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Daily Amount of Exogenous Insulin (Total Daily Bolus + Total Daily Basal) Required Calculated Over Days 3 to 27 (Treatment Outpatient Period)
|
-27.00 percent change
Interval -40.65 to -13.35
|
-1.20 percent change
Interval -10.03 to 7.63
|
-15.52 percent change
Interval -24.93 to -6.12
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: Analysis was performed on ITT population.
Baseline was defined as the last non-missing assessment prior to first dose of study drug. Change in FPG was calculated by subtracting baseline value from Day 29 value. LS Means and CI for the Expansion groups were based on a linear mixed repeated measures model.
Outcome measures
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=17 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=16 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29
|
-54.2 milligram/deciliter (mg/dL)
Interval -85.1 to -23.4
|
10.0 milligram/deciliter (mg/dL)
Interval -9.4 to 29.3
|
-12.5 milligram/deciliter (mg/dL)
Interval -36.8 to 11.8
|
SECONDARY outcome
Timeframe: Prior to start of mixed meal and 30, 60, 90, 120 and 180 min post start of mixed meal, on Day 1 and Day 29Population: Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. Data for this outcome measure was not analyzed for Pioneer Group participants.
A MMTT with frequent blood sample collection and with urine collection was performed on Day 1 and Day 29. Participants fasted (with the exception of water or non-caffeinated, calorie-free beverages) for at least 8 hours before the start of the MMTT and until the final blood sample was collected. Study drug was to be given within 15 minutes before liquid "Boost® Original" breakfast. The area under the plasma concentration-time curve (AUC) from time-zero to 3h postdose on Day 1 and Day 29 was calculated using the linear-up/log-down trapezoidal rule. Change was calculated by subtracting Day 1 value from Day 29 value. LS Means and CI were based on a linear mixed model.
Outcome measures
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=16 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=16 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Change From Day 1 in 3-hour Plasma Glucose AUC (AUC0-3 h) Following a Mixed Meal Tolerance Test (MMTT) at Day 29: Expansion Groups
|
-140.83 mg*h/dL
Interval -225.45 to -56.2
|
-308.51 mg*h/dL
Interval -393.51 to -223.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 3 to Day 27Population: Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Change in percent time per day spent in euglycemic range was calculated by subtracting baseline value from Day 29 value. LS Means and CI for the Expansion groups were based on a mixed model. LS mean and CI for the Pioneer Group were based on the arithmetic treatment mean.
Outcome measures
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=15 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=13 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Change From Baseline in Percent Time Per Day Spent in Euglycemic Range (>=70 and <=180 mg/dL) Over Days 3 to 27 (Treatment Outpatient Period) Based on Continuous Glucose Monitoring
|
6.6 percent time per day
Interval -31.4 to 44.7
|
-1.2 percent time per day
Interval -6.7 to 4.3
|
11.1 percent time per day
Interval 5.3 to 16.9
|
SECONDARY outcome
Timeframe: From 15 minutes before start of mixed meal until 180 min post start of mixed meal, on Day 1 and Day 29Population: Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. Data for this outcome measure was not analyzed for Pioneer Group participants.
A MMTT with frequent blood sample collection and with urine collection was performed on Day 1 and Day 29. Participants fasted (with the exception of water or non-caffeinated, calorie-free beverages) for at least 8 hours before the start of the MMTT and until the final blood sample was collected. Study drug was to be given within 15 minutes before liquid "Boost® Original" breakfast. Participants were asked to void immediately before blood sample 15 minutes before start of mixed meal and immediately after the 180-minute (3 hour) blood sample was collected, and all urine between the -15 minute and post-180-minute time points was collected for urine glucose calculation. Change was calculated by subtracting Day 1 value from Day 29 value. LS Means were based on a linear mixed model.
Outcome measures
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=13 Participants
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=16 Participants
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Change From Day 1 in 3-hour Urinary Glucose Excretion Following a Mixed Meal Tolerance Test (MMTT) to Day 29: Expansion Groups
|
-6.34 gram per 3 hour
Interval -20.57 to 7.89
|
8.30 gram per 3 hour
Interval -4.68 to 21.29
|
—
|
Adverse Events
Sotagliflozin 400 mg - Pioneer Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo - Expansion Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Sotagliflozin 400 mg - Expansion Group
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=17 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=16 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
12.5%
2/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
Other adverse events
| Measure |
Sotagliflozin 400 mg - Pioneer Group
n=3 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
|
Placebo - Expansion Group
n=17 participants at risk
Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
|
Sotagliflozin 400 mg - Expansion Group
n=16 participants at risk
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
ABNORMAL FAECES
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
11.8%
2/17 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
12.5%
2/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Nervous system disorders
DIZZINESS
|
33.3%
1/3 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
FAECES HARD
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
12.5%
2/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Nervous system disorders
HEADACHE
|
33.3%
1/3 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
11.8%
2/17 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
18.8%
3/16 • Number of events 3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
LICE INFESTATION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
33.3%
1/3 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Surgical and medical procedures
NAIL OPERATION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
11.8%
2/17 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
12.5%
2/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
1/3 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
25.0%
4/16 • Number of events 4 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Renal and urinary disorders
POLLAKIURIA
|
33.3%
1/3 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
General disorders
PYREXIA
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Nervous system disorders
SINUS HEADACHE
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
12.5%
2/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Skin and subcutaneous tissue disorders
SKIN IRRITATION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
11.8%
2/17 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/16 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
0.00%
0/17 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
6.2%
1/16 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/3 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
5.9%
1/17 • Number of events 1 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
12.5%
2/16 • Number of events 2 • All Adverse Events (AEs) were collected from Day 1 until the end of study (up to 40 days ).
Safety population included all participants who were randomized and received at least 1 dose of study drug. Participants in this population were assigned to the treatment group as they were treated on Day 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER