Trial Outcomes & Findings for This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam (NCT NCT03325712)
NCT ID: NCT03325712
Last Updated: 2022-09-07
Results Overview
Percentage of participants with drug-related adverse events is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564") or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Results posted on
2022-09-07
Participant Flow
The evaluation of multiple rising dose (MRD) of BI 705564 was designed as randomised, placebo-controlled, double-blind and parallel-group design and the evaluation of midazolam interaction was designed as nested, open-label, fixed-sequence, intra-individual comparison in healthy male participants.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all strictly inclusion/exclusion criteria. Participants were not to be assigned to treatment groups if any of the specific entry criteria were violated.
Participant milestones
| Measure |
Placebo Matching BI 705564
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
2
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
10
|
2
|
8
|
8
|
6
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Matching BI 705564
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 705564
n=10 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=2 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.1 Years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
33.0 Years
STANDARD_DEVIATION 2.8 • n=107 Participants
|
34.8 Years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
44.0 Years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
32.3 Years
STANDARD_DEVIATION 9.1 • n=31 Participants
|
38.4 Years
STANDARD_DEVIATION 8.3 • n=30 Participants
|
40.5 Years
STANDARD_DEVIATION 10.2 • n=3 Participants
|
28.5 Years
STANDARD_DEVIATION 10.7 • n=6 Participants
|
36.9 Years
STANDARD_DEVIATION 9.7 • n=114 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
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
60 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
60 Participants
n=114 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
|
|
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
|
|
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
|
1 Participants
n=6 Participants
|
1 Participants
n=114 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
|
|
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
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
55 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 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
|
2 Participants
n=114 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
|
PRIMARY outcome
Timeframe: From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564") or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").Population: Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Percentage of participants with drug-related adverse events is reported.
Outcome measures
| Measure |
Placebo Matching BI 705564
n=10 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=2 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events
|
20.0 Percentage of participants (%)
|
50.0 Percentage of participants (%)
|
12.5 Percentage of participants (%)
|
0.0 Percentage of participants (%)
|
50.0 Percentage of participants (%)
|
50.0 Percentage of participants (%)
|
12.5 Percentage of participants (%)
|
75.0 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: 1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded.
Area under the concentration-time curve of BI 705564 in plasma over a uniform dosing interval τ after administration of the first dose of BI 705564 (AUCτ,1) is reported. Here AUCτ,1 = AUC0-24.
Outcome measures
| Measure |
Placebo Matching BI 705564
n=8 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 705564 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1)
|
42.1 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 40.6
|
70.8 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 31.7
|
131.0 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 22.4
|
168.0 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 40.1
|
238.0 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 46.6
|
120.0 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 33.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded.
Maximum measured concentration of BI 705564 in plasma (Cmax) after the administration of the first dose of BI 705564 is reported.
Outcome measures
| Measure |
Placebo Matching BI 705564
n=8 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) After the Administration of the First Dose
|
11.4 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 42.2
|
18.8 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 38.2
|
36.5 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 17.8
|
41.0 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 28.1
|
58.1 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 54.4
|
31.7 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 35.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded. Only participants with evaluable results for this PK parameter are reported.
Area under the concentration-time curve of BI 705564 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the administration of the last dose of BI 705564 is reported. As per the protocol, day is counted as "Day 1 = 0:00".
Outcome measures
| Measure |
Placebo Matching BI 705564
n=8 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=6 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Administration of the Last Dose
|
45.9 nanomole *hour/liter (nmol*h/L)
Geometric Coefficient of Variation 34.2
|
84.8 nanomole *hour/liter (nmol*h/L)
Geometric Coefficient of Variation 25.9
|
164.0 nanomole *hour/liter (nmol*h/L)
Geometric Coefficient of Variation 34.3
|
170.0 nanomole *hour/liter (nmol*h/L)
Geometric Coefficient of Variation 62.1
|
204.0 nanomole *hour/liter (nmol*h/L)
Geometric Coefficient of Variation 179.0
|
138.0 nanomole *hour/liter (nmol*h/L)
Geometric Coefficient of Variation 32.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).Population: Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was not excluded. Only participants with evaluable results for this PK parameter are reported.
Maximum measured concentration of BI 705564 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the administration of the last dose. As per the protocol, day is counted as "Day 1 = 0:00".
Outcome measures
| Measure |
Placebo Matching BI 705564
n=8 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=6 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Administration of the Last Dose
|
13.3 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 29.4
|
19.8 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 23.7
|
41.8 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 21.4
|
43.4 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 57.2
|
52.6 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 201.0
|
39.2 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 28.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.Population: Pharmacokinetic (PK) parameter analysis set (PKS)-midazolam set (PKS-Mida): This set included all subjects in dose groups 2 to 5 who received midazolam (including placebo-treated subjects). Only participants with evaluable results for this PK parameter are reported.
Area under the concentration-time curve of Midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.
Outcome measures
| Measure |
Placebo Matching BI 705564
n=8 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) After the First and Last Dose
After last dose: Midazolam + BI705564 or Midazolam + Placebo (Treatment (T))
|
4478.58 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.10
|
3463.24 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.06
|
4812.45 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.11
|
3458.32 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.29
|
3759.20 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.10
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) After the First and Last Dose
After first dose: Midazolam alone (Reference (R))
|
4356.03 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.10
|
3721.70 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.06
|
4382.24 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.1
|
3191.16 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.29
|
3445.42 picomole*hour/Liter (pmol*h/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.10
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.Population: Pharmacokinetic (PK) parameter analysis set (PKS)-midazolam set (PKS-Mida): This set included all subjects in dose groups 2 to 5 who received midazolam (including placebo-treated subjects). Only participants with evaluable results for this PK parameter are reported.
Maximum measured concentration of Midazolam in plasma (Cmax) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.
Outcome measures
| Measure |
Placebo Matching BI 705564
n=8 Participants
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=8 Participants
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 Participants
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of Midazolam in Plasma (Cmax) After the First and Last Dose
After first dose: Midazolam alone (Reference (R))
|
1196.63 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.10
|
1232.26 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.09
|
1147.40 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.11
|
1031.18 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.26
|
1175.41 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.11
|
—
|
—
|
—
|
|
Maximum Measured Concentration of Midazolam in Plasma (Cmax) After the First and Last Dose
After last dose: Midazolam +BI 705564 or Midazolam +Placebo (Treatment (T))
|
1197.89 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.10
|
1040.42 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.09
|
1255.36 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.11
|
984.14 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.26
|
1058.32 picomole/Liter (pmol/L)
Standard Error NA
Standard error is actually adjusted geometric standard error. Geometric standard error=1.11
|
—
|
—
|
—
|
Adverse Events
Placebo Matching BI 705564
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Matching BI 705564 - SPT
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Group 1: BI 705564 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Group 2: BI 705564 20 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Group 3: BI 705564 40 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Group 5: BI 705564 60 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Group 4: BI 705564 80 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Group 8: BI 705564 40 mg - SPT
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Matching BI 705564
n=10 participants at risk
Participants were orally administered placebo matching to BI 705564 film-coated tablets (and 75 microgram (μg) Midazolam solution for injection, for dose groups 2-5) with 240 milliliter (mL) of water after a standard continental breakfast, on Day 1 and once per day on Days 4 to 17 (for placebo) and on Day -1 and Day 17 (for Midazolam).
|
Placebo Matching BI 705564 - SPT
n=2 participants at risk
Participants with a positive skin prick test (SPT) were orally administered once daily for 28 days placebo matching to BI 705564 film-coated tablets with 240 milliliter (mL) of water after breakfast.
|
Dose Group 1: BI 705564 10 mg
n=8 participants at risk
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 1 film-coated tablet of 10 milligram (mg) of BI 705564 with 240 milliliter (mL) of water after a standard continental breakfast.
|
Dose Group 2: BI 705564 20 mg
n=8 participants at risk
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 2 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=20 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 3: BI 705564 40 mg
n=8 participants at risk
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 5: BI 705564 60 mg
n=8 participants at risk
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 6 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=60 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (μg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 4: BI 705564 80 mg
n=8 participants at risk
Participants were orally administered one single dose on Day 1 and once daily on Days 4 to 17, 8 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=80 mg) with 240 milliliter (mL) of water after a standard continental breakfast. On Day -1 and on Day 17 participants were orally administered also 75 microgram (µg) of solution for injection of midazolam with 240 mL of water after a standard continental breakfast.
|
Dose Group 8: BI 705564 40 mg - SPT
n=8 participants at risk
Participants with a positive skin prick test (SPT) were orally administered for 28 days once daily 4 film-coated tablets of 10 milligram (mg) of BI 705564 (total dosage=40 mg) with 240 milliliter (mL) of water after breakfast.
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
37.5%
3/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Fatigue
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Pain
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
1/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
50.0%
4/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Orthostatic intolerance
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
37.5%
3/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
25.0%
2/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
|
Vascular disorders
Haematoma
|
10.0%
1/10 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/2 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
12.5%
1/8 • From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").
Treated Set (TS): This subject set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER