Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes (NCT NCT04465877)
NCT ID: NCT04465877
Last Updated: 2023-01-27
Results Overview
Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
6 Weeks (from Day -1 to the follow-up visit on Day 42)
Results posted on
2023-01-27
Participant Flow
Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.
Following informed consent signing, screening procedures to confirm eligibility were performed. All subjects received a single dose of placebo on Day -1 (Placebo Run-in Period) followed by JTT-662 or placebo once-daily (QD) for 28 consecutive days (Day 1 through Day 28).
Participant milestones
| Measure |
JTT-662 5 mg
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
Placebo orally once daily from Day -1 to Day 28
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
10
|
9
|
|
Overall Study
Randomized Population
|
9
|
9
|
10
|
9
|
|
Overall Study
Safety Population
|
9
|
9
|
10
|
9
|
|
Overall Study
PK (Pharmacokinetic) Population
|
9
|
9
|
10
|
0
|
|
Overall Study
PD (Pharmacodynamic) Population
|
9
|
9
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
JTT-662 5 mg
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
Placebo orally once daily from Day -1 to Day 28
|
|---|---|---|---|---|
|
Overall Study
Noncompliant with study requirements
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
JTT-662 5 mg
n=9 Participants
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
n=9 Participants
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
n=10 Participants
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
n=9 Participants
Placebo orally once daily from Day -1 to Day 28
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
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
|
|
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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 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
|
0 Participants
n=21 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
|
PRIMARY outcome
Timeframe: 6 Weeks (from Day -1 to the follow-up visit on Day 42)Population: Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.
Outcome measures
| Measure |
JTT-662 5 mg
n=9 Participants
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
n=9 Participants
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
n=10 Participants
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
n=9 Participants
Placebo orally once daily from Day -1 to Day 28
|
Placebo Run-in
n=37 Participants
Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1
|
|---|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events
Number of subjects with no TEAEs
|
5 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
34 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events
Number of subjects with TEAEs
|
4 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 7 Weeks (from Day -6 to the follow-up visit on Day 42)Population: Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.
Outcome measures
| Measure |
JTT-662 5 mg
n=9 Participants
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
n=9 Participants
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
n=10 Participants
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
n=9 Participants
Placebo orally once daily from Day -1 to Day 28
|
Placebo Run-in
Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1
|
|---|---|---|---|---|---|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Type 6
|
73 Number of stools
|
94 Number of stools
|
242 Number of stools
|
25 Number of stools
|
—
|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Total Number of Stools
|
491 Number of stools
|
550 Number of stools
|
815 Number of stools
|
599 Number of stools
|
—
|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Type 1
|
15 Number of stools
|
3 Number of stools
|
9 Number of stools
|
4 Number of stools
|
—
|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Type 2
|
31 Number of stools
|
12 Number of stools
|
11 Number of stools
|
17 Number of stools
|
—
|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Type 3
|
41 Number of stools
|
21 Number of stools
|
18 Number of stools
|
102 Number of stools
|
—
|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Type 4
|
226 Number of stools
|
173 Number of stools
|
119 Number of stools
|
329 Number of stools
|
—
|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Type 5
|
63 Number of stools
|
117 Number of stools
|
106 Number of stools
|
97 Number of stools
|
—
|
|
Number of Stools and Type of Stools Based on Bristol Stool Chart
Type 7
|
42 Number of stools
|
130 Number of stools
|
310 Number of stools
|
25 Number of stools
|
—
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: PK Population consists of subjects randomized to JTT-662 treatment groups who received at least one dose of JTT-662 and had available PK data. The number of subjects on Days 21 and 28 is only 27 since 1 subject in the JTT-662 20 mg group discontinued the study on Day 19.
Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.
Outcome measures
| Measure |
JTT-662 5 mg
n=9 Participants
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
n=9 Participants
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
n=10 Participants
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
Placebo orally once daily from Day -1 to Day 28
|
Placebo Run-in
Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1
|
|---|---|---|---|---|---|
|
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Day 15
|
266 ng/mL
Standard Deviation 83.7
|
689 ng/mL
Standard Deviation 209
|
1140 ng/mL
Standard Deviation 475
|
—
|
—
|
|
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Day 21
|
281 ng/mL
Standard Deviation 100
|
787 ng/mL
Standard Deviation 237
|
1180 ng/mL
Standard Deviation 665
|
—
|
—
|
|
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Day 1
|
60.2 ng/mL
Standard Deviation 14.4
|
124 ng/mL
Standard Deviation 36.0
|
231 ng/mL
Standard Deviation 61.9
|
—
|
—
|
|
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Day 7
|
209 ng/mL
Standard Deviation 61.5
|
518 ng/mL
Standard Deviation 155
|
845 ng/mL
Standard Deviation 359
|
—
|
—
|
|
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Day 10
|
235 ng/mL
Standard Deviation 64.3
|
629 ng/mL
Standard Deviation 181
|
959 ng/mL
Standard Deviation 449
|
—
|
—
|
|
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Day 14
|
257 ng/mL
Standard Deviation 97.3
|
703 ng/mL
Standard Deviation 224
|
1130 ng/mL
Standard Deviation 502
|
—
|
—
|
|
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Day 28
|
292 ng/mL
Standard Deviation 103
|
786 ng/mL
Standard Deviation 326
|
1190 ng/mL
Standard Deviation 583
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 14 and 28Population: PD Population consists of subjects who were randomly assigned to treatment, received at least one dose of JTT-662 or placebo starting on Day 1 and had evaluable PD data. For the JTT-662 20 mg group, number of participants analyzed on Day 28 is 9 since 1 subject did not complete the study.
Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.
Outcome measures
| Measure |
JTT-662 5 mg
n=9 Participants
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
n=9 Participants
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
n=10 Participants
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
n=9 Participants
Placebo orally once daily from Day -1 to Day 28
|
Placebo Run-in
Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1
|
|---|---|---|---|---|---|
|
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
Day 1
|
-0.34 mg*hr/dL
Interval -55.64 to 54.96
|
-98.24 mg*hr/dL
Interval -153.78 to -42.69
|
-88.19 mg*hr/dL
Interval -140.71 to -35.67
|
1.78 mg*hr/dL
Interval -54.0 to 57.57
|
—
|
|
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
Day 14
|
-31.22 mg*hr/dL
Interval -106.31 to 43.88
|
-169.40 mg*hr/dL
Interval -244.67 to -94.13
|
-253.57 mg*hr/dL
Interval -324.85 to -182.29
|
-31.55 mg*hr/dL
Interval -106.99 to 43.89
|
—
|
|
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
Day 28
|
-61.17 mg*hr/dL
Interval -154.63 to 32.28
|
-230.87 mg*hr/dL
Interval -324.46 to -137.28
|
-250.64 mg*hr/dL
Interval -340.71 to -160.58
|
-1.83 mg*hr/dL
Interval -95.55 to 91.9
|
—
|
Adverse Events
JTT-662 5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
JTT-662 10 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
JTT-662 20 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Run-in
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
JTT-662 5 mg
n=9 participants at risk
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 10 mg
n=9 participants at risk
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
JTT-662 20 mg
n=10 participants at risk
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
|
Placebo
n=9 participants at risk
Placebo orally once daily from Day -1 to Day 28
|
Placebo Run-in
n=37 participants at risk
Subjects randomized in all 4 treatment groups (JTT-662 5 mg, JTT-662 10 mg, JTT-662 20 mg and Placebo) received a single dose of Placebo on Day -1
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
30.0%
3/10 • Number of events 3 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
3/9 • Number of events 4 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
55.6%
5/9 • Number of events 5 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
100.0%
10/10 • Number of events 12 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
5.4%
2/37 • Number of events 2 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Infections and infestations
Abscess
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
2.7%
1/37 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 2 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/10 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/9 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
0.00%
0/37 • Up to 6 weeks (from Day -1 to the follow-up visit on Day 42)
Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications at least 60 days prior to public release. The sponsor will have a review period of 60 days and can embargo communications regarding trial results for an additional period of 60 days from the end of sponsor review period. The sponsor may require removal of any and all confidential information (other than study results) in the communication.
- Publication restrictions are in place
Restriction type: OTHER