Trial Outcomes & Findings for BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects (NCT NCT02976519)
NCT ID: NCT02976519
Last Updated: 2019-11-27
Results Overview
Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Up to 44 days (for Part 1) or 51 days (for Part 2) (Please check the measure description for detailed timeframe)
Results posted on
2019-11-27
Participant Flow
The trial was conducted in 2 parts. The first part was a multiple rising dose (MRD) trial in healthy participants. The second part followed a cross-over design with respect to placebo and BI 443651 treatment in participants with cystic fibrosis. Both parts were randomised, placebo-controlled, and double-blinded.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Placebo Matching BI 443651
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 600 μg/ Placebo Matching BI 443651
Participants suffering from cystic fibrosis were treated with 600 μg BI 443651 dose in period 1 and followed by placebo matching to BI 443651 in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
|
Placebo Matching BI 443651/ BI 443651 600 μg
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 in period 1 and followed by 600 μg BI 443651 dose in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (Part 1 and Part 2)
STARTED
|
8
|
8
|
8
|
8
|
8
|
12
|
12
|
|
Treatment Period 1 (Part 1 and Part 2)
COMPLETED
|
8
|
7
|
8
|
7
|
8
|
12
|
12
|
|
Treatment Period 1 (Part 1 and Part 2)
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Wash-out Period (Part 2 Only)
STARTED
|
0
|
0
|
0
|
0
|
0
|
12
|
12
|
|
Wash-out Period (Part 2 Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
12
|
10
|
|
Wash-out Period (Part 2 Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Treatment Period 2 (Part 2 Only)
STARTED
|
0
|
0
|
0
|
0
|
0
|
12
|
10
|
|
Treatment Period 2 (Part 2 Only)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
12
|
9
|
|
Treatment Period 2 (Part 2 Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Matching BI 443651
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 600 μg/ Placebo Matching BI 443651
Participants suffering from cystic fibrosis were treated with 600 μg BI 443651 dose in period 1 and followed by placebo matching to BI 443651 in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
|
Placebo Matching BI 443651/ BI 443651 600 μg
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 in period 1 and followed by 600 μg BI 443651 dose in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
|
|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (Part 1 and Part 2)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (Part 1 and Part 2)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Wash-out Period (Part 2 Only)
Reason not listed
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Wash-out Period (Part 2 Only)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (Part 2 Only)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 443651
n=8 Participants
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
n=8 Participants
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
n=8 Participants
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
n=8 Participants
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
n=8 Participants
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 600 μg/ Placebo Matching BI 443651
n=12 Participants
Participants suffering from cystic fibrosis were treated with 600 μg BI 443651 dose in period 1 and followed by placebo matching to BI 443651 in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
|
Placebo Matching BI 443651/ BI 443651 600 μg
n=12 Participants
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 in period 1 and followed by 600 μg BI 443651 dose in period 2, both administered via Respimat® inhaler twice daily for 13.5 days treatment periods separated by a wash-out period of at least 30 days between drug administrations in Part 2.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.8 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
39.1 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
38.9 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
32.1 Years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
41.1 Years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
38.3 Years
STANDARD_DEVIATION 12.4 • n=10 Participants
|
34.0 Years
STANDARD_DEVIATION 8.1 • n=115 Participants
|
37.1 Years
STANDARD_DEVIATION 9.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
56 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
64 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
56 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 44 days (for Part 1) or 51 days (for Part 2) (Please check the measure description for detailed timeframe)Population: TS
Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.
Outcome measures
| Measure |
Placebo Matching BI 443651
n=8 Participants
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
n=8 Participants
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
n=8 Participants
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
n=8 Participants
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
n=8 Participants
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
Placebo Matching BI 443651 600 μg
n=24 Participants
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
BI 443651 600 μg
n=22 Participants
Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2
|
37.5 Percentage of participants (%)
|
62.5 Percentage of participants (%)
|
87.5 Percentage of participants (%)
|
100.0 Percentage of participants (%)
|
87.5 Percentage of participants (%)
|
58.3 Percentage of participants (%)
|
59.1 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: Day 1 and Day 7 (Please check the measure description for detailed timeframe)Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the TS who provided at least 1 PK parameter that was not excluded.
Maximum measured concentration of the BI 443651 in plasma after the administration of the first dose (Cmax) on day 1 and over the time interval from 0 to 12 h after the 13th dose (Cmax,13) on day 7, in Part 1. Pharmacokinetic samples were collected at 00:15 hours:minutes (h:m) pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for Cmax) and after last drug administration on day 7 (for Cmax,13).
Outcome measures
| Measure |
Placebo Matching BI 443651
n=8 Participants
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
n=7 Participants
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
n=8 Participants
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
n=8 Participants
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
Placebo Matching BI 443651 600 μg
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
BI 443651 600 μg
Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1
Cmax
|
158 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 60.8
|
782 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 46.8
|
3400 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 64.7
|
6320 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 48.2
|
—
|
—
|
—
|
|
Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1
Cmax,13
|
250 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 31.9
|
745 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 70.3
|
4000 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 27.2
|
6060 picomole (pmol)/Litre (L)
Geometric Coefficient of Variation 70.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7 (Please check the measure description for detailed timeframe)Population: PKS
Area under the concentration-time curve of the BI 443651 in plasma over the time interval from 0 to 12 hours (h) after the administration of the first dose (AUC0-12) on day 1 and after the 13th dose (AUC0-12,13) on day 7 in Part 1. Pharmacokinetic samples were collected at 00:15 h:m pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for AUC0-12) and after last drug administration on day 7 (for AUC0-12,13).
Outcome measures
| Measure |
Placebo Matching BI 443651
n=8 Participants
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
n=7 Participants
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
n=8 Participants
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
n=8 Participants
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
Placebo Matching BI 443651 600 μg
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
BI 443651 600 μg
Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1
AUC0-12
|
409 pmol*h/L
Geometric Coefficient of Variation 50.5
|
1980 pmol*h/L
Geometric Coefficient of Variation 47.7
|
9150 pmol*h/L
Geometric Coefficient of Variation 59.6
|
16200 pmol*h/L
Geometric Coefficient of Variation 43.9
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1
AUC0-12,13
|
868 pmol*h/L
Geometric Coefficient of Variation 35.3
|
2260 pmol*h/L
Geometric Coefficient of Variation 54.0
|
12200 pmol*h/L
Geometric Coefficient of Variation 37.6
|
18400 pmol*h/L
Geometric Coefficient of Variation 54.6
|
—
|
—
|
—
|
Adverse Events
Placebo Matching BI 443651
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 443651 100 Microgram (μg)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 443651 400 μg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 443651 1200 μg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 443651 1800 μg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Matching BI 443651 600 μg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
BI 443651 600 μg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Matching BI 443651
n=8 participants at risk
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
n=8 participants at risk
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
n=8 participants at risk
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
n=8 participants at risk
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
n=8 participants at risk
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
Placebo Matching BI 443651 600 μg
n=24 participants at risk
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
BI 443651 600 μg
n=22 participants at risk
Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
4.2%
1/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
Other adverse events
| Measure |
Placebo Matching BI 443651
n=8 participants at risk
Healthy participants were treated with placebo matching to BI 443651 via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 100 Microgram (μg)
n=8 participants at risk
Healthy participants were treated with BI 443651 100 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 400 μg
n=8 participants at risk
Healthy participants were treated with BI 443651 400 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1200 μg
n=8 participants at risk
Healthy participants were treated with BI 443651 1200 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
BI 443651 1800 μg
n=8 participants at risk
Healthy participants were treated with BI 443651 1800 μg dose via Respimat® inhaler twice daily for 6.5 days in Part 1.
|
Placebo Matching BI 443651 600 μg
n=24 participants at risk
Participants suffering from cystic fibrosis were treated with placebo matching to BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
BI 443651 600 μg
n=22 participants at risk
Participants suffering from cystic fibrosis were treated with BI 443651 600 μg dose via Respimat® twice daily for 13.5 days in Part 2.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
9.1%
2/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
62.5%
5/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
62.5%
5/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
4.2%
1/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
13.6%
3/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
37.5%
3/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
62.5%
5/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
50.0%
4/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
25.0%
2/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
8.3%
2/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
13.6%
3/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
50.0%
4/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
25.0%
6/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
22.7%
5/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
4.2%
1/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Infections and infestations
Viral infection
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
4.5%
1/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
General disorders
Medical device site rash
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
12.5%
1/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/8 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/24 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
0.00%
0/22 • From the first dose of study medication until 30 days after the day of last intake of study medication, up to 37 days (for Part 1) and up to 44 days (for Part 2).
Treated set (TS): The TS included all randomised subjects who had been treated with at least 1 dose of trial medication.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER