Trial Outcomes & Findings for This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam (NCT NCT03754959)
NCT ID: NCT03754959
Last Updated: 2025-04-03
Results Overview
Number of subjects with on-treatment drug-related Adverse Events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Midazolam: Up to 1 day, BI 1358894 or Placebo + Midazolam: Up to 1 day and BI 1358894: Up to 13 days.
Results posted on
2025-04-03
Participant Flow
Safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1358894 (double-blind, randomised, placebo-controlled, parallel-group design) and evaluation of midazolam interaction (nested, open, fixed-sequence, intra-individual comparison) in healthy male subjects
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they met all implemented inclusion/exclusion criteria, Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated
Participant milestones
| Measure |
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 Placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam
Baseline characteristics by cohort
| Measure |
Placebo Matching BI 1358894 Dose Group
n=10 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 Placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.1 Years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
32.0 Years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
32.4 Years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
32.3 Years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
29.3 Years
STANDARD_DEVIATION 1.8 • n=31 Participants
|
26.3 Years
STANDARD_DEVIATION 5.1 • n=30 Participants
|
30.8 Years
STANDARD_DEVIATION 7.2 • n=3 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
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
50 Participants
n=3 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
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
48 Participants
n=3 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
|
|
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
|
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
49 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
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
|
PRIMARY outcome
Timeframe: Midazolam: Up to 1 day, BI 1358894 or Placebo + Midazolam: Up to 1 day and BI 1358894: Up to 13 days.Population: Treated set (TS): all subjects who received at least one dose of study drug. This was the full analysis set population in the sense of ICH-E9.
Number of subjects with on-treatment drug-related Adverse Events (AEs).
Outcome measures
| Measure |
Midazolam
n=50 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=10 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=8 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
n=8 Participants
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
n=8 Participants
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
n=10 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
n=8 Participants
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With On-treatment Drug-related Adverse Events (AEs).
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.Population: Pharmacokinetic parameter set (PKS): all subjects in the TS who provided at least 1 PK parameter that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability, only subjects with available data were included in the endpoint.
Area under the concentration-time curve of the analyte in plasma over a time interval 0 to 24 hours (h) after administration of the first dose (AUC0-24).
Outcome measures
| Measure |
Midazolam
n=8 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=8 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=6 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over a Time Interval 0 to 24 h After Administration of the First Dose
|
801 nanomols * hours per liter
Geometric Coefficient of Variation 22.7
|
1570 nanomols * hours per liter
Geometric Coefficient of Variation 28.0
|
2690 nanomols * hours per liter
Geometric Coefficient of Variation 17.5
|
5520 nanomols * hours per liter
Geometric Coefficient of Variation 18.3
|
8200 nanomols * hours per liter
Geometric Coefficient of Variation 13.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.Population: Pharmacokinetic parameter set (PKS): all subjects in the TS who provided at least 1 PK parameter that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability, only subjects with available data were included in the endpoint.
Maximum measured concentration of the analyte BI 1358894 in plasma (Cmax).
Outcome measures
| Measure |
Midazolam
n=8 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=8 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=7 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1358894 in Plasma
|
78.8 Nanomol per liter
Geometric Coefficient of Variation 16.0
|
152 Nanomol per liter
Geometric Coefficient of Variation 34.7
|
217 Nanomol per liter
Geometric Coefficient of Variation 28.3
|
491 Nanomol per liter
Geometric Coefficient of Variation 17.2
|
634 Nanomol per liter
Geometric Coefficient of Variation 20.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.Population: Pharmacokinetic parameter set (PKS): all subjects in the TS who provided at least 1 PK parameter that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability, only subjects with available data were included in the endpoint.
Area under the concentration-time curve of BI 1358894 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Outcome measures
| Measure |
Midazolam
n=8 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=7 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=7 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma at Steady State Over a Uniform Dosing Interval τ
|
2070 nanomol * hours per liter
Geometric Coefficient of Variation 27.1
|
3520 nanomol * hours per liter
Geometric Coefficient of Variation 27.8
|
5890 nanomol * hours per liter
Geometric Coefficient of Variation 35.1
|
12600 nanomol * hours per liter
Geometric Coefficient of Variation 16.3
|
18900 nanomol * hours per liter
Geometric Coefficient of Variation 13.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 2 hours before and 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 27, 48, 72, 75, 96, 120, 123, 144, 192, 195, 240, 243, 288, 311, 312.17, 312.33, 312.5, 313, 314, 315, 316, 318, 320, 324, 336, 360, 384, 408, 432, 456, 504 hours after administration.Population: Pharmacokinetic parameter set (PKS): all subjects in the TS who provided at least 1 PK parameter that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability, only subjects with available data were included in the endpoint.
Maximum measured concentration of BI 1358894 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Outcome measures
| Measure |
Midazolam
n=8 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=7 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=7 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1358894 in Plasma at Steady State Over a Uniform Dosing Interval τ
|
138 nanomol per liter
Geometric Coefficient of Variation 14.5
|
225 nanomol per liter
Geometric Coefficient of Variation 18.8
|
383 nanomol per liter
Geometric Coefficient of Variation 26.7
|
843 nanomol per liter
Geometric Coefficient of Variation 19.8
|
1150 nanomol per liter
Geometric Coefficient of Variation 13.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 25.5, 23.83, 23.5, 23, 22, 21.5, 21, 20, 18, 16 and 1 hour before and 0.17, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 311, 312.33, 312.5, 313, 314, 314.5, 315, 316, 318 and 320 hours after administration of BI 1358894 .Population: PKS-Midazolam (PKS-MDZ): all subjects from the TS receiving BI 1358894 or placebo and midazolam who provided at least one secondary PK parameter for midazolam that was not excluded according to the description above. It was used for investigation of relative bioavailability
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
Midazolam
n=10 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=8 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=8 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
n=8 Participants
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (Day 1)
Midazolam + BI 1358894 or Placebo
|
2960 picomol * hours per liter
Geometric Coefficient of Variation 31.8
|
3630 picomol * hours per liter
Geometric Coefficient of Variation 47.2
|
3120 picomol * hours per liter
Geometric Coefficient of Variation 29.6
|
2810 picomol * hours per liter
Geometric Coefficient of Variation 37.2
|
3360 picomol * hours per liter
Geometric Coefficient of Variation 26.3
|
2480 picomol * hours per liter
Geometric Coefficient of Variation 24.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (Day 1)
Midazolam
|
3030 picomol * hours per liter
Geometric Coefficient of Variation 28.6
|
3790 picomol * hours per liter
Geometric Coefficient of Variation 46.0
|
3090 picomol * hours per liter
Geometric Coefficient of Variation 28.6
|
3000 picomol * hours per liter
Geometric Coefficient of Variation 40.2
|
3610 picomol * hours per liter
Geometric Coefficient of Variation 22.1
|
2750 picomol * hours per liter
Geometric Coefficient of Variation 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 25.5, 23.83, 23.5, 23, 22, 21.5, 21, 20, 18, 16 and 1 hour before and 0.17, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 311, 312.33, 312.5, 313, 314, 314.5, 315, 316, 318 and 320 hours after administration of BI 1358894.Population: PKS-Midazolam (PKS-MDZ): all subjects from the TS receiving BI 1358894 or placebo and midazolam who provided at least one secondary PK parameter for midazolam that was not excluded according to the description above. It was used for investigation of relative bioavailability
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
Midazolam
n=10 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=8 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=8 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
n=8 Participants
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (Day 14)
Midazolam + BI 1358894 or Placebo
|
3200 picomol * hours per liter
Geometric Coefficient of Variation 28.9
|
4450 picomol * hours per liter
Geometric Coefficient of Variation 43.3
|
3360 picomol * hours per liter
Geometric Coefficient of Variation 26.0
|
3440 picomol * hours per liter
Geometric Coefficient of Variation 17.3
|
3480 picomol * hours per liter
Geometric Coefficient of Variation 23.6
|
2460 picomol * hours per liter
Geometric Coefficient of Variation 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (Day 14)
Midazolam
|
3030 picomol * hours per liter
Geometric Coefficient of Variation 28.6
|
3790 picomol * hours per liter
Geometric Coefficient of Variation 46.0
|
3090 picomol * hours per liter
Geometric Coefficient of Variation 28.6
|
3000 picomol * hours per liter
Geometric Coefficient of Variation 40.2
|
3610 picomol * hours per liter
Geometric Coefficient of Variation 22.1
|
2750 picomol * hours per liter
Geometric Coefficient of Variation 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 25.5, 23.83, 23.5, 23, 22, 21.5, 21, 20, 18, 16 and 1 hour before and 0.17, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 311, 312.33, 312.5, 313, 314, 314.5, 315, 316, 318 and 320 hours after administration of BI 1358894.Population: PKS-Midazolam (PKS-MDZ): all subjects from the TS receiving BI 1358894 or placebo and midazolam who provided at least one secondary PK parameter for midazolam that was not excluded according to the description above. It was used for investigation of relative bioavailability
Maximum measured concentration of midazolam in plasma (Cmax).
Outcome measures
| Measure |
Midazolam
n=10 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=8 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=8 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
n=8 Participants
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of Midazolam in Plasma (Day 1)
Midazolam + BI 1358894 or placeobo (T)
|
913 picomole per liter
Geometric Coefficient of Variation 26.2
|
1090 picomole per liter
Geometric Coefficient of Variation 32.1
|
1130 picomole per liter
Geometric Coefficient of Variation 30.5
|
920 picomole per liter
Geometric Coefficient of Variation 32.8
|
1150 picomole per liter
Geometric Coefficient of Variation 19.0
|
812 picomole per liter
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Measured Concentration of Midazolam in Plasma (Day 1)
Midazolam (R)
|
929 picomole per liter
Geometric Coefficient of Variation 25.6
|
1120 picomole per liter
Geometric Coefficient of Variation 34.1
|
963 picomole per liter
Geometric Coefficient of Variation 42.0
|
974 picomole per liter
Geometric Coefficient of Variation 35.0
|
1170 picomole per liter
Geometric Coefficient of Variation 8.89
|
828 picomole per liter
Geometric Coefficient of Variation 30.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 25.5, 23.83, 23.5, 23, 22, 21.5, 21, 20, 18, 16 and 1 hour before and 0.17, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 311, 312.33, 312.5, 313, 314, 314.5, 315, 316, 318 and 320 hours after administration of BI 1358894.Population: PKS-Midazolam (PKS-MDZ): all subjects from the TS receiving BI 1358894 or placebo and midazolam who provided at least one secondary PK parameter for midazolam that was not excluded according to the description above. It was used for investigation of relative bioavailability
Maximum measured concentration of midazolam in plasma (Cmax).
Outcome measures
| Measure |
Midazolam
n=10 Participants
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=8 Participants
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=8 Participants
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 Participants
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 Participants
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
n=8 Participants
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of Midazolam in Plasma (Day 14)
Midazolam + BI 1358894 or placeobo (T)
|
887 picomole per liter
Geometric Coefficient of Variation 27.1
|
1180 picomole per liter
Geometric Coefficient of Variation 28.2
|
1070 picomole per liter
Geometric Coefficient of Variation 31.0
|
1090 picomole per liter
Geometric Coefficient of Variation 27.3
|
985 picomole per liter
Geometric Coefficient of Variation 29.3
|
722 picomole per liter
Geometric Coefficient of Variation 18.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Measured Concentration of Midazolam in Plasma (Day 14)
Midazolam (R)
|
929 picomole per liter
Geometric Coefficient of Variation 25.6
|
1120 picomole per liter
Geometric Coefficient of Variation 34.1
|
963 picomole per liter
Geometric Coefficient of Variation 42.0
|
974 picomole per liter
Geometric Coefficient of Variation 35.0
|
1170 picomole per liter
Geometric Coefficient of Variation 8.89
|
828 picomole per liter
Geometric Coefficient of Variation 30.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Midazolam
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo + Midazolam
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1358894 10 mg + Midazolam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1358894 25 mg + Midazolam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1358894 50 mg + Midazolam
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1358894 100 mg + Midazolam
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1358894 200 mg + Midazolam
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Matching BI 1358894 Dose Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BI 1358894 10 Milligram (mg) Dose Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1358894 25 Milligram (mg) Dose Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 1358894 50 Milligram (mg) Dose Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1358894 100 Milligram (mg) Dose Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1358894 200 Milligram (mg) Dose Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midazolam
n=50 participants at risk
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo
|
Placebo + Midazolam
n=10 participants at risk
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 mg + Midazolam
n=8 participants at risk
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 mg + Midazolam
n=8 participants at risk
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894was administered immediately prior to midazolam.
|
BI 1358894 50 mg + Midazolam
n=8 participants at risk
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 mg + Midazolam
n=8 participants at risk
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 mg + Midazolam
n=8 participants at risk
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
Placebo Matching BI 1358894 Dose Group
n=10 participants at risk
Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 10 Milligram (mg) Dose Group
n=8 participants at risk
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 25 Milligram (mg) Dose Group
n=8 participants at risk
Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 50 Milligram (mg) Dose Group
n=8 participants at risk
Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 100 Milligram (mg) Dose Group
n=8 participants at risk
Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
BI 1358894 200 Milligram (mg) Dose Group
n=8 participants at risk
Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
37.5%
3/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
37.5%
3/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
25.0%
2/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
25.0%
2/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
37.5%
3/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
40.0%
4/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
62.5%
5/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
62.5%
5/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
40.0%
4/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
25.0%
2/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
12.5%
1/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/50 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
10.0%
1/10 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
0.00%
0/8 • Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Treated set (TS): all subjects who received at least one dose of study drug.
|
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