Trial Outcomes & Findings for A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants (NCT NCT03847987)
NCT ID: NCT03847987
Last Updated: 2020-05-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 to Day 5
Results posted on
2020-05-28
Participant Flow
Healthy male and female participants between ages 18-55 years, who were nonsmokers for at least 6 months.
Participant milestones
| Measure |
Part 1
Sixteen (16) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
* Treatment A = A single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
* Treatment B = A single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
* Treatment C = A single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
* Treatment D = A single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
Treatment sequences were randomly assigned
|
Part 2
Eight (8) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
* Treatment A (taste assessment) = A single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
* Treatment B (taste assessment) = A single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
Treatment sequences were randomly assigned
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
COMPLETED
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Part 1
Sixteen (16) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
* Treatment A = A single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
* Treatment B = A single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
* Treatment C = A single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
* Treatment D = A single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
Treatment sequences were randomly assigned
|
Part 2
Eight (8) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
* Treatment A (taste assessment) = A single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
* Treatment B (taste assessment) = A single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
Treatment sequences were randomly assigned
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1
n=16 Participants
Sixteen (16) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
* Treatment A = A single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
* Treatment B = A single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
* Treatment C = A single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
* Treatment D = A single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
Treatment sequences were randomly assigned
|
Part 2
n=8 Participants
Eight (8) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
* Treatment A (taste assessment) = A single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
* Treatment B (taste assessment) = A single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
Treatment sequences were randomly assigned
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.1 Years
STANDARD_DEVIATION 9.66 • n=93 Participants
|
35.3 Years
STANDARD_DEVIATION 10.57 • n=4 Participants
|
33.7 Years
STANDARD_DEVIATION 4.44 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 5Population: The PK population included all participants.
Outcome measures
| Measure |
Part 1 - Treatment A
n=16 Participants
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
|
Part 1 - Treatment B
n=16 Participants
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
|
Part 1 - Treatment C
n=16 Participants
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
|
Part 1 - Treatment D
n=16 Participants
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
|
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
|
Part 2 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
|
1320 ng/mL
Geometric Coefficient of Variation 25.8
|
1570 ng/mL
Geometric Coefficient of Variation 27.4
|
1120 ng/mL
Geometric Coefficient of Variation 25.3
|
1490 ng/mL
Geometric Coefficient of Variation 26.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 5Outcome measures
| Measure |
Part 1 - Treatment A
n=8 Participants
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
|
Part 1 - Treatment B
n=8 Participants
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
|
Part 1 - Treatment C
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
|
Part 1 - Treatment D
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
|
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
|
Part 2 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
|
|---|---|---|---|---|---|---|
|
Cmax of RO7017773 (Part 2)
|
1470 ng/mL
Geometric Coefficient of Variation 25.2
|
1210 ng/mL
Geometric Coefficient of Variation 19.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: The populations for this taste assessment were Part 2 - Treatment A and Part 2 - Treatment B.
Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste.
Outcome measures
| Measure |
Part 1 - Treatment A
n=8 Participants
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
|
Part 1 - Treatment B
n=8 Participants
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
|
Part 1 - Treatment C
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
|
Part 1 - Treatment D
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
|
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
|
Part 2 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
|
|---|---|---|---|---|---|---|
|
Taste Assessment, as Measured by Taste Questionnaire (Part 2)
|
3 Units on a Scale
Interval 1.0 to 4.0
|
1.5 Units on a Scale
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The population for this taste assessment was Part 1 - Treatment D (study drug dispersed in water).
Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste.
Outcome measures
| Measure |
Part 1 - Treatment A
n=14 Participants
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
|
Part 1 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
|
Part 1 - Treatment C
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
|
Part 1 - Treatment D
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
|
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
|
Part 2 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
|
|---|---|---|---|---|---|---|
|
Taste Assessment, as Measured by Taste Questionnaire (Part 1)
|
2 Units on a Scale
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through end of study (approximately 6 weeks)Outcome measures
| Measure |
Part 1 - Treatment A
n=16 Participants
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
|
Part 1 - Treatment B
n=16 Participants
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
|
Part 1 - Treatment C
n=16 Participants
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
|
Part 1 - Treatment D
n=16 Participants
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
|
Part 2 - Treatment A
n=8 Participants
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
|
Part 2 - Treatment B
n=8 Participants
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
56.3 Percentage of Participants
|
60.0 Percentage of Participants
|
53.3 Percentage of Participants
|
28.6 Percentage of Participants
|
75.0 Percentage of Participants
|
62.5 Percentage of Participants
|
Adverse Events
Part 1 - Treatment A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1 - Treatment B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1 - Treatment C
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1 - Treatment D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2 - Treatment A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 - Treatment B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 - Treatment A
n=16 participants at risk
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
|
Part 1 - Treatment B
n=15 participants at risk
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
|
Part 1 - Treatment C
n=15 participants at risk；n=14 participants at risk
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
|
Part 1 - Treatment D
n=14 participants at risk
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
|
Part 2 - Treatment A
n=8 participants at risk
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
|
Part 2 - Treatment B
n=8 participants at risk
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
12.5%
1/8 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
|
General disorders
Pain
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Investigations
Blood pressure increased
|
6.2%
1/16 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Nervous system disorders
Somnolence
|
12.5%
2/16 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
13.3%
2/15 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
21.4%
3/14 • Number of events 3 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
62.5%
5/8 • Number of events 5 • Baseline through end of study (up to approximately 6 weeks)
|
25.0%
2/8 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Number of events 5 • Baseline through end of study (up to approximately 6 weeks)
|
26.7%
4/15 • Number of events 4 • Baseline through end of study (up to approximately 6 weeks)
|
13.3%
2/15 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
37.5%
3/8 • Number of events 3 • Baseline through end of study (up to approximately 6 weeks)
|
50.0%
4/8 • Number of events 4 • Baseline through end of study (up to approximately 6 weeks)
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
14.3%
2/14 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
25.0%
2/8 • Number of events 2 • Baseline through end of study (up to approximately 6 weeks)
|
12.5%
1/8 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
7.1%
1/14 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
6.7%
1/15 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/16 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/15 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/14 • Baseline through end of study (up to approximately 6 weeks)
|
12.5%
1/8 • Number of events 1 • Baseline through end of study (up to approximately 6 weeks)
|
0.00%
0/8 • Baseline through end of study (up to approximately 6 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER