Trial Outcomes & Findings for This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated (NCT NCT03315936)
NCT ID: NCT03315936
Last Updated: 2024-03-18
Results Overview
Percentage of participants with drug-related adverse events (AEs) in SRD part. Percentages are calculated using total number of subjects per treatment as the denominator. Percentages were rounded up to 1 decimal places.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
From drug administration until end of the trial, up to 17 days.
Results posted on
2024-03-18
Participant Flow
Single rising dose (SRD) part was designed as single-blind, partially randomized within dose groups, placebo-controlled, parallel-group design and relative bioavailability (rel BA) part was an open-label, randomized two-way crossover followed by a fixed sequence design in healthy volunteers.
All participants were screened for eligibility to participate in the trial. Participants attended specialized site which would ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered/randomised to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Placebo Matching BI 894416 (SRD Part)
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 10mg tb / 10mg PfOS / 40mg tb
Participants were administered single dose of BI 894416 10 mg tablet (tb) in period 1 followed by BI 894416 10 mg powder for oral solution in period 2 followed by BI 894416 4\*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part.
|
BI 894416 10mg PfOS / 10mg tb / 40mg tb
Participants were administered single dose of BI 894416 10 mg powder for oral solution in period 1 followed by BI 894416 10 mg tablet (tb) in period 2 followed by BI 894416 4\*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
14
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
14
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Period 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=14 Participants
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 10mg tb / 10mg PfOS / 40mg tb
n=6 Participants
Participants were administered single dose of BI 894416 10 mg tablet (tb) in period 1 followed by BI 894416 10 mg powder for oral solution in period 2 followed by BI 894416 4\*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part.
|
BI 894416 10mg PfOS / 10mg tb / 40mg tb
n=6 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution in period 1 followed by BI 894416 10 mg tablet (tb) in period 2 followed by BI 894416 4\*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.8 Years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
33.2 Years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
33.5 Years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
35.7 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
33.7 Years
STANDARD_DEVIATION 7.0 • n=31 Participants
|
38.2 Years
STANDARD_DEVIATION 6.3 • n=30 Participants
|
34.3 Years
STANDARD_DEVIATION 5.5 • n=3 Participants
|
34.2 Years
STANDARD_DEVIATION 9.1 • n=6 Participants
|
31.7 Years
STANDARD_DEVIATION 8.3 • n=114 Participants
|
30.5 Years
STANDARD_DEVIATION 6.9
|
33.9 Years
STANDARD_DEVIATION 7.0 • n=19 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
68 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
66 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
6 Participants
|
67 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: From drug administration until end of the trial, up to 17 days.Population: Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
Percentage of participants with drug-related adverse events (AEs) in SRD part. Percentages are calculated using total number of subjects per treatment as the denominator. Percentages were rounded up to 1 decimal places.
Outcome measures
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=14 Participants
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events in SRD Part
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
33.3 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) in SRD part is presented.
Outcome measures
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=6 Participants
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) in SRD Part
|
345 nanomole (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 34.9
|
640 nanomole (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 101.0
|
1470 nanomole (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 96.7
|
3270 nanomole (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 27.1
|
6020 nanomole (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 20.6
|
7210 nanomole (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 28.1
|
11400 nanomole (nmol) * hour (h) / Litre (L)
Geometric Coefficient of Variation 29.6
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability.
Maximum measured concentration of BI 894416 in plasma (Cmax) in SRD part is presented.
Outcome measures
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=6 Participants
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
n=6 Participants
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 894416 in Plasma (Cmax) in SRD Part
|
55.4 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 11.1
|
161.0 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 37.5
|
352.0 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 26.9
|
527.0 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 31.3
|
1170.0 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 26.4
|
1240.0 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 23.0
|
2130.0 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 16.7
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis.
Outcome measures
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=12 Participants
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=12 Participants
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=12 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) in Rel BA Part
|
941 nanomole (nmol) * hour (h)/Litre (L)
Geometric Coefficient of Variation 95.2
|
853 nanomole (nmol) * hour (h)/Litre (L)
Geometric Coefficient of Variation 89.0
|
5870 nanomole (nmol) * hour (h)/Litre (L)
Geometric Coefficient of Variation 61.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability.
Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis.
Outcome measures
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=12 Participants
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=12 Participants
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=12 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) in Rel BA Part
|
975 nanomole (nmol) * hour (h)/Litre (L)
Geometric Coefficient of Variation 97.5
|
879 nanomole (nmol) * hour (h)/Litre (L)
Geometric Coefficient of Variation 90.4
|
6060 nanomole (nmol) * hour (h)/Litre (L)
Geometric Coefficient of Variation 63.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability.
Maximum measured concentration of BI 894416 in plasma (Cmax) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis.
Outcome measures
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=12 Participants
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=12 Participants
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=12 Participants
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 894416 in Plasma (Cmax) in Rel BA Part
|
199 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 39.5
|
180 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 53.4
|
1160 nanomole (nmol)/Litre (L)
Geometric Coefficient of Variation 39.2
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo Matching BI 894416 (SRD Part)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 894416 3 Milligram (mg) (SRD Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 894416 10 mg (SRD Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 894416 20 mg (SRD Part)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 894416 30 mg (SRD Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 894416 40 mg (SRD Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 894416 54 mg (SRD Part)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 894416 70 mg (SRD Part)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 894416 10 mg PfOS (R)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 894416 10 mg tb (T)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 894416 40 mg tb
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Matching BI 894416 (SRD Part)
n=14 participants at risk
Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 3 Milligram (mg) (SRD Part)
n=6 participants at risk
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part.
|
BI 894416 10 mg (SRD Part)
n=6 participants at risk
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 20 mg (SRD Part)
n=6 participants at risk
Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 30 mg (SRD Part)
n=6 participants at risk
Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 40 mg (SRD Part)
n=6 participants at risk
Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 54 mg (SRD Part)
n=6 participants at risk
Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 70 mg (SRD Part)
n=6 participants at risk
Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part.
|
BI 894416 10 mg PfOS (R)
n=12 participants at risk
Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in rel BA part.
|
BI 894416 10 mg tb (T)
n=12 participants at risk
Participants were administered single dose of BI 894416 10 mg tablet with 240 mL of water after an overnight fast of at least 10 h in rel BA part.
|
BI 894416 40 mg tb
n=12 participants at risk
Participants were administered single dose of BI 894416 4\*10 mg tablets with 240 mL of water after an overnight fast of at least 10 h in rel BA part.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
33.3%
2/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
7.1%
1/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Gastrointestinal disorders
Oral papule
|
7.1%
1/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
33.3%
2/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
33.3%
2/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
33.3%
2/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
2/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
16.7%
1/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
General disorders
Fatigue
|
7.1%
1/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
8.3%
1/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Eye disorders
Ocular discomfort
|
7.1%
1/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
|
Immune system disorders
Seasonal allergy
|
7.1%
1/14 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/6 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
0.00%
0/12 • For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place