Trial Outcomes & Findings for This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood (NCT NCT03210272)
NCT ID: NCT03210272
Last Updated: 2025-03-25
Results Overview
Percentage of subjects with drug-related adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
83 participants
Primary outcome timeframe
From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Results posted on
2025-03-25
Participant Flow
Single rising oral doses of BI 1358894 in healthy male subjects (single-blind, partially randomised, placebo-controlled parallel group design) and effect of food on the relative bioavailability of BI 1358894 (open-label, randomised, two-way cross-over)
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they met all implemented inclusion/exclusion criteria, Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated
Participant milestones
| Measure |
Placebo
matching placebo Single Rising Dose (SRD) part
|
BI 3mg
oral administration of BI 1358894 film-coated tablet (3\*1 milligram (mg) tablet) Single Rising Dose (SRD) part
|
BI 6mg
oral administration of BI 1358894 film-coated tablet (6\*1mg tablet) Single Rising Dose (SRD) part
|
BI 10mg
oral administration of BI 1358894 film-coated tablet (2\*5mg tablet) Single Rising Dose (SRD) part
|
BI 25mg
oral administration of BI 1358894 film-coated tablet (1\*25mg tablet) Single Rising Dose (SRD) part
|
BI 50mg
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) Single Rising Dose (SRD) part
|
BI 100mg
oral administration of BI 1358894 film-coated tablet (1\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fast
oral administration of BI 1358894 film-coated tablet in fasting status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fed
oral administration of BI 1358894 film-coated tablet in fed status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 50mg Fed / BI 50mg Fast
oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg)/ oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg) Food effect (FE) part
|
BI 50mg Fast / BI 50m Fed
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg) / oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg) Food effect (FE) part
|
BI 100mg Fed / BI 100mg Fast
oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg)/ oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg) Food effect (FE) part
|
BI 100mg Fast / BI 100m Fed
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg)/ oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg) Food effect (FE) part
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
4
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
15
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
4
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
matching placebo Single Rising Dose (SRD) part
|
BI 3mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (3\*1 milligram (mg) tablet) Single Rising Dose (SRD) part
|
BI 6mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (6\*1mg tablet) Single Rising Dose (SRD) part
|
BI 10mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*5mg tablet) Single Rising Dose (SRD) part
|
BI 25mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*25mg tablet) Single Rising Dose (SRD) part
|
BI 50mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) Single Rising Dose (SRD) part
|
BI 100mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fast
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fasting status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fed
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fed status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 50mg Fed / BI 50mg Fast
n=4 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg)/ oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg) Food effect (FE) part
|
BI 50mg Fast / BI 50m Fed
n=4 Participants
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg) / oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg) Food effect (FE) part
|
BI 100mg Fed / BI 100mg Fast
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg)/ oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg) Food effect (FE) part
|
BI 100mg Fast / BI 100m Fed
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg)/ oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg) Food effect (FE) part
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.7 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
40.2 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
33.7 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
36.2 Years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
36.2 Years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
40.2 Years
STANDARD_DEVIATION 3.5 • n=8 Participants
|
35.5 Years
STANDARD_DEVIATION 6.6 • n=8 Participants
|
38.3 Years
STANDARD_DEVIATION 7.0 • n=24 Participants
|
28.0 Years
STANDARD_DEVIATION 3.6 • n=42 Participants
|
36.8 Years
STANDARD_DEVIATION 8.8 • n=42 Participants
|
32.5 Years
STANDARD_DEVIATION 8.3 • n=42 Participants
|
34.2 Years
STANDARD_DEVIATION 10.2 • n=42 Participants
|
30.0 Years
STANDARD_DEVIATION 8.1 • n=36 Participants
|
34.9 Years
STANDARD_DEVIATION 7.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
83 Participants
n=36 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
80 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)Population: Treated Set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Percentage of subjects with drug-related adverse events
Outcome measures
| Measure |
Placebo
n=15 Participants
matching placebo Single Rising Dose (SRD) part
|
BI 3mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (3\*1 milligram (mg) tablet) Single Rising Dose (SRD) part
|
BI 6mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (6\*1mg tablet) Single Rising Dose (SRD) part
|
BI 10mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*5mg tablet) Single Rising Dose (SRD) part
|
BI 25mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*25mg tablet) Single Rising Dose (SRD) part
|
BI 50mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) Single Rising Dose (SRD) part
|
BI 100mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fast
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fasting status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fed
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fed status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 50mg Fed
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg), Food effect (FE) part
|
BI 50mg Fast
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg), Food effect (FE) part
|
BI 100mg Fed
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg), Food effect (FE) part
|
BI 100mg Fast
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg), Food effect (FE) part
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug- Related Adverse Event
|
0.0 Percentage
|
16.7 Percentage
|
50.0 Percentage
|
0.0 Percentage
|
33.3 Percentage
|
66.7 Percentage
|
66.7 Percentage
|
50.0 Percentage
|
66.7 Percentage
|
87.5 Percentage
|
87.5 Percentage
|
50.0 Percentage
|
66.7 Percentage
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administrationPopulation: Pharmacokinetic parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the TS receiving BI 1358894 who provided at least 1 secondary PK parameter (AUC or Cmax) that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints
Area under the concentration-time curve of the analyte BI1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Outcome measures
| Measure |
Placebo
n=6 Participants
matching placebo Single Rising Dose (SRD) part
|
BI 3mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (3\*1 milligram (mg) tablet) Single Rising Dose (SRD) part
|
BI 6mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (6\*1mg tablet) Single Rising Dose (SRD) part
|
BI 10mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*5mg tablet) Single Rising Dose (SRD) part
|
BI 25mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*25mg tablet) Single Rising Dose (SRD) part
|
BI 50mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) Single Rising Dose (SRD) part
|
BI 100mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fast
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fasting status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fed
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fed status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 50mg Fed
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg), Food effect (FE) part
|
BI 50mg Fast
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg), Food effect (FE) part
|
BI 100mg Fed
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg), Food effect (FE) part
|
BI 100mg Fast
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg), Food effect (FE) part
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity
|
341 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 20.7
|
596 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 33.3
|
922 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 20.4
|
2540 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 29.9
|
4470 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 25.5
|
2960 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 1570
|
13700 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 45.7
|
33800 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 30.1
|
4920 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 27.1
|
7660 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 41.0
|
7020 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 56.4
|
16900 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 21.5
|
—
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administrationPopulation: Pharmacokinetic parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the TS receiving BI 1358894 who provided at least 1 secondary PK parameter (AUC or Cmax) that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints
Area under the concentration-time curve of the analyte BI1358894 in plasma over the time interval from 0 to the last quantifiable data time point (AUC0-tz).
Outcome measures
| Measure |
Placebo
n=6 Participants
matching placebo Single Rising Dose (SRD) part
|
BI 3mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (3\*1 milligram (mg) tablet) Single Rising Dose (SRD) part
|
BI 6mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (6\*1mg tablet) Single Rising Dose (SRD) part
|
BI 10mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*5mg tablet) Single Rising Dose (SRD) part
|
BI 25mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*25mg tablet) Single Rising Dose (SRD) part
|
BI 50mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) Single Rising Dose (SRD) part
|
BI 100mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fast
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fasting status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fed
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fed status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 50mg Fed
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg), Food effect (FE) part
|
BI 50mg Fast
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg), Food effect (FE) part
|
BI 100mg Fed
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg), Food effect (FE) part
|
BI 100mg Fast
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg), Food effect (FE) part
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Time Point
|
288 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 18.5
|
569 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 32.7
|
861 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 17.7
|
2380 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 29.7
|
4170 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 26.2
|
2520 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 2670
|
12600 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 42.0
|
32800 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 29.0
|
4440 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 23.5
|
6940 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 36.2
|
6320 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 53.4
|
15500 Nanomoles*Hour per Litre
Geometric Coefficient of Variation 19.3
|
—
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administrationPopulation: Pharmacokinetic parameter analysis set (PKS): The PK parameter analysis set (PKS) included all subjects from the TS receiving BI 1358894 who provided at least 1 secondary PK parameter (AUC or Cmax) that was not excluded because of protocol deviations relevant to the statistical evaluation of PK endpoints
Maximum measured concentration of the analyte BI 1358894 in plasma (Cmax).
Outcome measures
| Measure |
Placebo
n=6 Participants
matching placebo Single Rising Dose (SRD) part
|
BI 3mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (3\*1 milligram (mg) tablet) Single Rising Dose (SRD) part
|
BI 6mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (6\*1mg tablet) Single Rising Dose (SRD) part
|
BI 10mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*5mg tablet) Single Rising Dose (SRD) part
|
BI 25mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*25mg tablet) Single Rising Dose (SRD) part
|
BI 50mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) Single Rising Dose (SRD) part
|
BI 100mg
n=6 Participants
oral administration of BI 1358894 film-coated tablet (1\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fast
n=6 Participants
oral administration of BI 1358894 film-coated tablet in fasting status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fed
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fed status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 50mg Fed
n=8 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (2\*25mg), Food effect (FE) part
|
BI 50mg Fast
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (2\*25mg), Food effect (FE) part
|
BI 100mg Fed
n=12 Participants
oral administration of BI 1358894 film-coated tablet in fed state (Test) (1\*100mg), Food effect (FE) part
|
BI 100mg Fast
oral administration of BI 1358894 film-coated tablet in fasting state (Reference) (1\*100mg), Food effect (FE) part
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the Analyte BI 1358894 in Plasma
|
27.6 Nanomoles per Litre
Geometric Coefficient of Variation 30.0
|
35.9 Nanomoles per Litre
Geometric Coefficient of Variation 33.8
|
59.7 Nanomoles per Litre
Geometric Coefficient of Variation 13.4
|
84.2 Nanomoles per Litre
Geometric Coefficient of Variation 44.2
|
183 Nanomoles per Litre
Geometric Coefficient of Variation 56.3
|
94.3 Nanomoles per Litre
Geometric Coefficient of Variation 735
|
385 Nanomoles per Litre
Geometric Coefficient of Variation 26.8
|
857 Nanomoles per Litre
Geometric Coefficient of Variation 22.2
|
149 Nanomoles per Litre
Geometric Coefficient of Variation 59.4
|
237 Nanomoles per Litre
Geometric Coefficient of Variation 24.9
|
210 Nanomoles per Litre
Geometric Coefficient of Variation 38.8
|
517 Nanomoles per Litre
Geometric Coefficient of Variation 8.61
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 3mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 6mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 10mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 25mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 50mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 100mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 200mg Fast
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 200mg Fed
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI Total SRD
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
BI 50mg Fed
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 50mg Fast (R)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 100mg Fed (T)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 100mg Fast (R)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
matching placebo Single Rising Dose (SRD) part
|
BI 3mg
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet (3\*1 milligram (mg) tablet) Single Rising Dose (SRD) part
|
BI 6mg
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet (6\*1mg tablet) Single Rising Dose (SRD) part
|
BI 10mg
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet (2\*5mg tablet) Single Rising Dose (SRD) part
|
BI 25mg
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet (1\*25mg tablet) Single Rising Dose (SRD) part
|
BI 50mg
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) Single Rising Dose (SRD) part
|
BI 100mg
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet (1\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fast
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet in fasting status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI 200mg Fed
n=6 participants at risk
oral administration of BI 1358894 film-coated tablet in fed status (2\*100mg tablet) Single Rising Dose (SRD) part
|
BI Total SRD
n=48 participants at risk
total summary BI 1358894
|
BI 50mg Fed
n=8 participants at risk
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) in fed status (Test) Food effect (FE) part
|
BI 50mg Fast (R)
n=8 participants at risk
oral administration of BI 1358894 film-coated tablet (2\*25mg tablet) in fasting status (Reference) Food effect (FE) part
|
BI 100mg Fed (T)
n=12 participants at risk
oral administration of BI 1358894 film-coated tablet (1\*100 mg tablet) in fed status (Test) Food effect (FE) part
|
BI 100mg Fast (R)
n=12 participants at risk
oral administration of BI 1358894 film-coated tablet (1\*100 mg tablet) in fasting status (Reference) Food effect (FE) part
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Ear and labyrinth disorders
Auditory disorder
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
General disorders
Fatigue
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
2/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
8.3%
1/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
8.3%
1/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
8.3%
1/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
25.0%
2/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
4.2%
2/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
25.0%
2/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
37.5%
3/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
2/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
25.0%
3/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
33.3%
2/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
66.7%
4/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
33.3%
2/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
50.0%
3/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
50.0%
3/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
50.0%
3/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
50.0%
3/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
41.7%
20/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
75.0%
6/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
87.5%
7/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
33.3%
4/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
58.3%
7/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
16.7%
1/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
2.1%
1/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
8.3%
1/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/15 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/6 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/48 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
12.5%
1/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/8 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
0.00%
0/12 • From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Treated set (TS): This subject set included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place