Trial Outcomes & Findings for Safety Tolerability and Pharmacokinetic of BI 409306 (NCT NCT01343706)
NCT ID: NCT01343706
Last Updated: 2024-04-25
Results Overview
Percentage of subjects with investigator defined drug-related Adverse Events (AEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
From first drug administration until 30 days after last drug administration; up to 31 days.
Results posted on
2024-04-25
Participant Flow
In this Phase 1, single centre, placebo-controlled trial (within dose groups), total of 80 healthy subjects were entered and 79 (71 CYP2C19 Extensive metaboliser /8 Poor CYP2C19 metaboliser) subjects were treated in 10 sequential dose groups.
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Placebo Matching to BI 409306 [EM and PM]
Extensive metaboliser \[EM\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours.
Poor metaboliser \[PM\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of placebo to BI 409306 tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
|
BI 409306 0.5 mg PiB [EM]
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB Followed by BI 409306 5 mg Tablet [EM]
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
|
BI 409306 10 mg Tablet [EM]
EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 25 mg Tablet [EM]
EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 50 mg Tablet Followed by BI 409306 50mg PiB [EM]
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.
|
Placebo to BI 409306 50 mg Tablet Followed by BI 409306 50 mg PiB [EM]
EM subject administered one single dose of placebo matching to the 50 mg BI 409306 film-coated tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution administered orally with 240 mL water in period 2, both after an overnight fast of at least 10 hours.
|
BI 409306 100 mg Tablet [EM]
EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 200 mg Tablet [EM]
EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 350 mg Tablet [EM]
EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 10 mg Tablet Followed by BI 409306 100mg Tablet [PM]
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
2
|
6
|
6
|
6
|
6
|
|
Overall Study
Not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
18
|
6
|
6
|
6
|
6
|
6
|
6
|
2
|
5
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TS
Baseline characteristics by cohort
| Measure |
Placebo Matching to BI 409306 [EM and PM]
n=18 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours.
Poor metaboliser \[PM\] subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) reconstituted for oral solution or one single dose of placebo matching to BI 409306 tablet orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of placebo to BI 409306 tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB Followed by BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 25 mg Tablet [EM]
n=6 Participants
EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 50 mg Tablet Followed by BI 409306 50mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.
|
Placebo to BI 409306 50 mg Tablet Followed by BI 409306 50 mg PiB [EM]
n=2 Participants
EM subject administered one single dose of placebo matching to the 50 mg BI 409306 film-coated tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution administered orally with 240 mL water in period 2, both after an overnight fast of at least 10 hours.
|
BI 409306 100 mg Tablet [EM]
n=5 Participants
EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 10 mg Tablet Followed by BI 409306 100mg Tablet [PM]
n=6 Participants
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=24 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=36 Participants • TS
|
|
Age, Continuous
|
38.2 Years
STANDARD_DEVIATION 5.6 • n=5 Participants • TS
|
36.5 Years
STANDARD_DEVIATION 9.2 • n=7 Participants • TS
|
37.5 Years
STANDARD_DEVIATION 6.5 • n=5 Participants • TS
|
35.7 Years
STANDARD_DEVIATION 8.2 • n=4 Participants • TS
|
30.5 Years
STANDARD_DEVIATION 5.9 • n=21 Participants • TS
|
32.2 Years
STANDARD_DEVIATION 6.5 • n=8 Participants • TS
|
40.3 Years
STANDARD_DEVIATION 6.1 • n=8 Participants • TS
|
37.5 Years
STANDARD_DEVIATION 3.5 • n=24 Participants • TS
|
31.4 Years
STANDARD_DEVIATION 7.3 • n=42 Participants • TS
|
38.5 Years
STANDARD_DEVIATION 6.7 • n=42 Participants • TS
|
39.2 Years
STANDARD_DEVIATION 8.8 • n=42 Participants • TS
|
39.5 Years
STANDARD_DEVIATION 7.5 • n=42 Participants • TS
|
36.7 Years
STANDARD_DEVIATION 7.1 • n=36 Participants • TS
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants • TS
|
6 Participants
n=7 Participants • TS
|
6 Participants
n=5 Participants • TS
|
6 Participants
n=4 Participants • TS
|
6 Participants
n=21 Participants • TS
|
6 Participants
n=8 Participants • TS
|
6 Participants
n=8 Participants • TS
|
2 Participants
n=24 Participants • TS
|
5 Participants
n=42 Participants • TS
|
6 Participants
n=42 Participants • TS
|
6 Participants
n=42 Participants • TS
|
6 Participants
n=42 Participants • TS
|
79 Participants
n=36 Participants • TS
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=24 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=36 Participants • TS
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=24 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=36 Participants • TS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=24 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=36 Participants • TS
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=24 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=36 Participants • TS
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants • TS
|
6 Participants
n=7 Participants • TS
|
6 Participants
n=5 Participants • TS
|
6 Participants
n=4 Participants • TS
|
6 Participants
n=21 Participants • TS
|
6 Participants
n=8 Participants • TS
|
6 Participants
n=8 Participants • TS
|
2 Participants
n=24 Participants • TS
|
5 Participants
n=42 Participants • TS
|
6 Participants
n=42 Participants • TS
|
6 Participants
n=42 Participants • TS
|
6 Participants
n=42 Participants • TS
|
79 Participants
n=36 Participants • TS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=24 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=36 Participants • TS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=7 Participants • TS
|
0 Participants
n=5 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=21 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=8 Participants • TS
|
0 Participants
n=24 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=42 Participants • TS
|
0 Participants
n=36 Participants • TS
|
PRIMARY outcome
Timeframe: From first drug administration until 30 days after last drug administration; up to 31 days.Population: Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Percentage of subjects with investigator defined drug-related Adverse Events (AEs)
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
n=20 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=4 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=8 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=5 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
n=6 Participants
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
n=6 Participants
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Drug-related Adverse Events
|
0.0 Percentage of subjects
|
0.0 Percentage of subjects
|
0.0 Percentage of subjects
|
33.3 Percentage of subjects
|
0.0 Percentage of subjects
|
16.7 Percentage of subjects
|
0.0 Percentage of subjects
|
0.0 Percentage of subjects
|
0.0 Percentage of subjects
|
0.0 Percentage of subjects
|
40.0 Percentage of subjects
|
66.7 Percentage of subjects
|
66.7 Percentage of subjects
|
33.3 Percentage of subjects
|
50.0 Percentage of subjects
|
PRIMARY outcome
Timeframe: Day 4Population: Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Percentage of subjects with Clinical Relevant abnormalities for Physical examination, Vital Signs blood pressure (BP), pulse rate (PR) respiratory rate (RR), orthostatic test), Clinical laboratory tests (haematology, clinical chemistry and urinalysis), Oral body temperature and ECG were reported.
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
n=20 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=4 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=8 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=5 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
n=6 Participants
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
n=6 Participants
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Clinical Laboratory Tests, Oral Body Temperature and ECG
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
PRIMARY outcome
Timeframe: Day 4Population: Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
The investigator assessed global clinical assessment and tolerability of BI 409306 were reported in possible categories were 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
n=18 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=2 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=5 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=6 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Per Category for Assessment of Tolerability by Investigator
Good
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
6 Percentage of subjects
|
2 Percentage of subjects
|
5 Percentage of subjects
|
6 Percentage of subjects
|
4 Percentage of subjects
|
4 Percentage of subjects
|
—
|
—
|
—
|
|
Percentage of Subjects Per Category for Assessment of Tolerability by Investigator
Satisfactory
|
0 Percentage of subjects
|
0 Percentage of subjects
|
1 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
2 Percentage of subjects
|
1 Percentage of subjects
|
—
|
—
|
—
|
|
Percentage of Subjects Per Category for Assessment of Tolerability by Investigator
Not satisfactory
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
1 Percentage of subjects
|
—
|
—
|
—
|
|
Percentage of Subjects Per Category for Assessment of Tolerability by Investigator
Bad
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
—
|
|
Percentage of Subjects Per Category for Assessment of Tolerability by Investigator
Not assessable
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
0 Percentage of subjects
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 24 hoursPopulation: Treated set (TS):This set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
The B\&L VAS scores were calculated from 16 item with each has a score range from 0 to 10 \[cm\]. The score of each of the 3 categories of effects ("alertness", "calmness", and "contentment") is a weighted average of the scores from the 16 items. The VAS score for alertness/calmness/contentment ranges from 0 to 10 (more alertness/calmness/contentment). The B\&L VAS data was analysed descriptively (change from baseline at 24 hour). The VAS assessment 2 h before drug administration was considered as baseline.
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
n=20 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=4 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=8 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=5 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
n=6 Participants
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
n=6 Participants
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)
Alertness
|
-0.33 Score on a scale
Standard Deviation 1.26
|
-0.04 Score on a scale
Standard Deviation 0.70
|
-0.84 Score on a scale
Standard Deviation 1.11
|
-1.18 Score on a scale
Standard Deviation 0.35
|
-0.13 Score on a scale
Standard Deviation 0.70
|
0.09 Score on a scale
Standard Deviation 0.56
|
-0.33 Score on a scale
Standard Deviation 0.73
|
-0.07 Score on a scale
Standard Deviation 0.97
|
-0.92 Score on a scale
Standard Deviation 1.25
|
-0.56 Score on a scale
Standard Deviation 0.54
|
-0.26 Score on a scale
Standard Deviation 0.95
|
-0.80 Score on a scale
Standard Deviation 0.55
|
-0.21 Score on a scale
Standard Deviation 0.39
|
-1.02 Score on a scale
Standard Deviation 1.24
|
-1.88 Score on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)
Contentment
|
-0.30 Score on a scale
Standard Deviation 1.09
|
0.06 Score on a scale
Standard Deviation 0.45
|
-0.74 Score on a scale
Standard Deviation 1.02
|
-0.68 Score on a scale
Standard Deviation 0.23
|
-0.53 Score on a scale
Standard Deviation 0.68
|
-0.12 Score on a scale
Standard Deviation 0.71
|
0.04 Score on a scale
Standard Deviation 0.46
|
0.00 Score on a scale
Standard Deviation 0.76
|
-0.49 Score on a scale
Standard Deviation 0.84
|
-0.35 Score on a scale
Standard Deviation 0.75
|
-0.19 Score on a scale
Standard Deviation 0.73
|
-0.59 Score on a scale
Standard Deviation 0.59
|
-0.22 Score on a scale
Standard Deviation 0.50
|
-0.64 Score on a scale
Standard Deviation 1.23
|
-0.97 Score on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS)
Calmness
|
-0.35 Score on a scale
Standard Deviation 1.34
|
0.02 Score on a scale
Standard Deviation 0.21
|
-0.48 Score on a scale
Standard Deviation 1.20
|
-0.91 Score on a scale
Standard Deviation 0.99
|
-0.45 Score on a scale
Standard Deviation 0.89
|
-0.14 Score on a scale
Standard Deviation 1.59
|
0.25 Score on a scale
Standard Deviation 1.04
|
-0.39 Score on a scale
Standard Deviation 0.55
|
-0.75 Score on a scale
Standard Deviation 1.35
|
-0.47 Score on a scale
Standard Deviation 1.71
|
0.05 Score on a scale
Standard Deviation 1.31
|
-0.55 Score on a scale
Standard Deviation 1.55
|
-0.17 Score on a scale
Standard Deviation 0.34
|
-0.47 Score on a scale
Standard Deviation 1.06
|
-0.38 Score on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.Population: Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax.
AUC0-24, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 to the time of the last quantifiable data point is presented as geometric mean (gMean) and geometric coefficient of variation (gCV%). Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=8 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=5 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=6 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-24)
|
3.96 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 50.3
|
20.90 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 41.30
|
76.70 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 27.00
|
75.60 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 32.29
|
96.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 69.90
|
351.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 49.30
|
539.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 82.00
|
648.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 42.90
|
1460.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 68.50
|
3920.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 44.40
|
7980.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 17.10
|
476.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 35.40
|
6060.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 21.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.Population: Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax.
AUC0-∞, Area under the concentration-time curve of the BI 409306 in plasma over the time interval from 0 extrapolated to infinity. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=8 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=5 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=6 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
3.95 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 50.40
|
20.90 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 41.30
|
76.70 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 27.00
|
75.60 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 32.20
|
95.90 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 69.80
|
351.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 49.40
|
539.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 82.00
|
648.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 42.90
|
1460.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 68.50
|
3920.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 44.40
|
7980.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 17.10
|
476.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 35.50
|
6060.00 nanomol*hour/Litre [nmol*h/L]
Geometric Coefficient of Variation 21.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2:00 (hour: minute) before 0.167, 0.333, 0.5, 0.75, 1:00, 1.50, 2:00, 2.50, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 hours after the drug administration.Population: Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax.
Cmax, Maximum measured concentration of the BI 409306 in plasma. Pharmacokinetic samples were also collected at 48:00 and 72:00 hours after the drug administration for dose groups 10 mg onwards.
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 Participants
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=8 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=5 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=6 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
|
3.54 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 34.50
|
18.80 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 50.80
|
56.40 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 36.40
|
55.90 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 40.90
|
99.80 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 79.10
|
300.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 85.00
|
479.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 67.00
|
613.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 40.70
|
1370.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 87.30
|
2950.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 89.50
|
5540.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 29.50
|
223.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 38.10
|
3120.00 nanomol/Litre (nmol/L)
Geometric Coefficient of Variation 31.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Urine samples were obtained pre-dose and sampling intervals 0:00 to 4:00, 4:00 to 8:00, 8:00 to 12:00 and 12:00 to 24:00 hours after oral administration.Population: Per protocol set for evaluation of PK (PPS-PK): This set included all evaluable subjects of the treated set who had no important protocol violations relevant to the evaluation of PK, who had no pre-dose value greater than 5% of Cmax and who did not vomit or had diarrhoea at or before two times median tmax. Only participants with non-missing outcomes were included in the analysis.
Ae0-4, Amount of BI 409306 eliminated in urine from the time point t1(0) to time point t2(4). Urine samples were obtained 24:00 to 48:00 and 48:00 to 72:00 hours after oral administration were obtained only from dose group 10 mg onwards.
Outcome measures
| Measure |
Placebo Matching to BI (Period 1)
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=6 Participants
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 Participants
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 Participants
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=5 Participants
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 10 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 25 mg Tablet [EM]
n=8 Participants
Subjects administered a single dose of 25 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 50 mg Tablet [EM]
n=4 Participants
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50 mg PiB [EM]
n=5 Participants
Subjects administered one single dose 50 ml BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 ml/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after washout period of 5 days both after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 100 mg Tablet [EM]
n=6 Participants
Subjects administered 2 single doses of 100 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 200 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 200 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 350 mg Tablet [EM]
n=6 Participants
Subjects administered a single dose of 350 mg BI 409306 immediate release tablets orally with 240 mL water after an overnight fast of at least 10 hours in extensive metabolizer \[EM\] group.
|
BI 409306 10 mg Tablet [PM]
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Amount of BI 409306 Eliminated in Urine From the Time Point t1 to Time Point t2 (Ae0-4)
|
—
|
31.00 nanomol [nmol]
Geometric Coefficient of Variation 46.50
|
93.60 nanomol [nmol]
Geometric Coefficient of Variation 26.00
|
98.10 nanomol [nmol]
Geometric Coefficient of Variation 24.20
|
148.00 nanomol [nmol]
Geometric Coefficient of Variation 60.20
|
—
|
840.00 nanomol [nmol]
Geometric Coefficient of Variation 56.90
|
953.00 nanomol [nmol]
Geometric Coefficient of Variation 48.10
|
1920.00 nanomol [nmol]
Geometric Coefficient of Variation 53.00
|
4340.00 nanomol [nmol]
Geometric Coefficient of Variation 48.80
|
8830.00 nanomol [nmol]
Geometric Coefficient of Variation 24.00
|
418.00 nanomol [nmol]
Geometric Coefficient of Variation 14.30
|
5700.00 nanomol [nmol]
Geometric Coefficient of Variation 23.30
|
—
|
—
|
Adverse Events
Placebo Matching to BI (Period 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Matching to BI (Period 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 409306 0.5 mg PiB [EM]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 409306 2 mg PiB [EM]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 409306 5 mg PiB [EM]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 409306 5 mg Tablet [EM]
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 409306 10 mg Tablet [EM]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 409306 25 mg Tablet [EM]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 409306 50 mg Tablet [EM]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 409306 50mg PiB [EM]
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 409306 100 mg Tablet [EM]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 409306 200 mg Tablet [EM]
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 409306 350 mg Tablet [EM]
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 409306 10 mg Tablet [PM]
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 409306 100 mg Tablet [PM]
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Matching to BI (Period 1)
n=20 participants at risk
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects randomized to placebo treatment (in period 1 only, if having 2 periods).
|
Placebo Matching to BI (Period 2)
n=4 participants at risk
Extensive metaboliser \[EM\] and poor metaboliser \[PM\] subjects administered placebo in period 2 (after a wash out period of 5 days).
|
BI 409306 0.5 mg PiB [EM]
n=6 participants at risk
Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 2 mg PiB [EM]
n=6 participants at risk
EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.
|
BI 409306 5 mg PiB [EM]
n=6 participants at risk
EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1.
|
BI 409306 5 mg Tablet [EM]
n=6 participants at risk
EM subjects administered one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 10 mg Tablet [EM]
n=6 participants at risk
EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 25 mg Tablet [EM]
n=6 participants at risk
EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 50 mg Tablet [EM]
n=6 participants at risk
EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1.
|
BI 409306 50mg PiB [EM]
n=8 participants at risk
EM subjects administered one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
BI 409306 100 mg Tablet [EM]
n=5 participants at risk
EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 200 mg Tablet [EM]
n=6 participants at risk
EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 350 mg Tablet [EM]
n=6 participants at risk
EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 409306 10 mg Tablet [PM]
n=6 participants at risk
Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1.
|
BI 409306 100 mg Tablet [PM]
n=6 participants at risk
PM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2 (after a washout period of 5 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
20.0%
1/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Photophobia
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
20.0%
1/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Photopsia
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
20.0%
1/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
33.3%
2/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
33.3%
2/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Feeling hot
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
1/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
33.3%
2/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
33.3%
2/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
20.0%
1/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
20.0%
1/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/4 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/5 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
16.7%
1/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/6 • From first drug administration until 30 days after last drug administration; up to 31 days.
The safety analysis was based on treated set (TS). TS includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place