MedTrace Logo

Trial Outcomes & Findings for A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People (NCT NCT06716190)

NCT ID: NCT06716190

Last Updated: 2026-08-10

Results Overview

The occurrence of any treatment-emergent adverse event (TEAE) assessed as drug-related by the investigator is reported as number of participants. The primary endpoint was analyzed without the microdose of midazolam on Day 1, as defined in the statistical analysis plan.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.

Results posted on

2026-08-10

Participant Flow

Multiple-rising dose (MRD) trial designed as single-blind, randomized within dose groups, and placebo-controlled parallel-group design to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 3731579 in healthy participants.

All participants were screened for eligibility prior to participation in the trial. The participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. The participants were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure
Placebo-matching BI 3731579 + Midazolam
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 1 and on Day 17, they took 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. On Day 17, midazolam was taken after placebo-matching BI 3731579.
Low-dose Bid BI 3731579 + Midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
Mid-dose Bid BI 3731579 + Midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
High-dose Bid BI 3731579 + Midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
Overall Study
STARTED
6
8
8
8
Overall Study
COMPLETED
6
8
8
8
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo-matching BI 3731579 + Midazolam
n=6 Participants
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 1 and on Day 17, they took 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. On Day 17, midazolam was taken after placebo-matching BI 3731579.
Low-dose Bid BI 3731579 + Midazolam
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
Mid-dose Bid BI 3731579 + Midazolam
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
High-dose Bid BI 3731579 + Midazolam
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
38.2 Years
STANDARD_DEVIATION 8.3 • n=54 Participants
41.0 Years
STANDARD_DEVIATION 6.3 • n=54 Participants
40.9 Years
STANDARD_DEVIATION 8.3 • n=27 Participants
36.9 Years
STANDARD_DEVIATION 9.0 • n=26 Participants
39.3 Years
STANDARD_DEVIATION 7.8 • n=161 Participants
Sex: Female, Male
Female
1 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
1 Participants
n=161 Participants
Sex: Female, Male
Male
5 Participants
n=54 Participants
8 Participants
n=54 Participants
8 Participants
n=27 Participants
8 Participants
n=26 Participants
29 Participants
n=161 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=161 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=54 Participants
8 Participants
n=54 Participants
8 Participants
n=27 Participants
8 Participants
n=26 Participants
30 Participants
n=161 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=161 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=161 Participants
Race (NIH/OMB)
Asian
0 Participants
n=54 Participants
1 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
1 Participants
n=161 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=161 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
1 Participants
n=161 Participants
Race (NIH/OMB)
White
5 Participants
n=54 Participants
7 Participants
n=54 Participants
8 Participants
n=27 Participants
8 Participants
n=26 Participants
28 Participants
n=161 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=161 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=54 Participants
0 Participants
n=54 Participants
0 Participants
n=27 Participants
0 Participants
n=26 Participants
0 Participants
n=161 Participants

PRIMARY outcome

Timeframe: From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.

Population: Treated set (TS) - all participants who were treated with at least one dose of the trial drug.

The occurrence of any treatment-emergent adverse event (TEAE) assessed as drug-related by the investigator is reported as number of participants. The primary endpoint was analyzed without the microdose of midazolam on Day 1, as defined in the statistical analysis plan.

Outcome measures

Outcome measures
Measure
Placebo-matching BI 3731579
n=6 Participants
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 17, participants took placebo-matching film-coated tablets of BI 3731579, orally, with 240 milliliters (mL) of water and 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. Midazolam was taken after placebo.
Low-dose Bid BI 3731579
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Mid-dose Bid BI 3731579
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
High-dose Bid BI 3731579
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Occurrence of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
0 Participants
4 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Up to 408 hours. Detailed timeframe in the description.

Population: Pharmacokinetic parameter analysis set (PKS): all participants who were treated with at least one dose of BI 3731579 and who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Area under the concentration-time curve of BI 3731579 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after its last dose is reported. Timeframe: 0.5 hours before first BI 3731579 administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 359.75, 360.25, 360.5, 361, 361.5, 362, 364, 365, 367, 369, 371, 372, 384, and 408 thereafter.

Outcome measures

Outcome measures
Measure
Placebo-matching BI 3731579
n=8 Participants
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 17, participants took placebo-matching film-coated tablets of BI 3731579, orally, with 240 milliliters (mL) of water and 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. Midazolam was taken after placebo.
Low-dose Bid BI 3731579
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Mid-dose Bid BI 3731579
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
High-dose Bid BI 3731579
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Area Under the Concentration-time Curve of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
7710 hours*nanomole/liter
Geometric Coefficient of Variation 18.7
23400 hours*nanomole/liter
Geometric Coefficient of Variation 31.9
54900 hours*nanomole/liter
Geometric Coefficient of Variation 27.2
—

SECONDARY outcome

Timeframe: Up to 408 hours. Detailed timeframe in the description.

Population: Pharmacokinetic parameter analysis set (PKS): all participants who were treated with at least one dose of BI 3731579 and who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Maximum measured concentration of BI 3731579 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after its last dose is reported. Timeframe: 0.5 hours before first BI 3731579 administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 359.75, 360.25, 360.5, 361, 361.5, 362, 364, 365, 367, 369, 371, 372, 384, and 408 thereafter.

Outcome measures

Outcome measures
Measure
Placebo-matching BI 3731579
n=8 Participants
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 17, participants took placebo-matching film-coated tablets of BI 3731579, orally, with 240 milliliters (mL) of water and 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. Midazolam was taken after placebo.
Low-dose Bid BI 3731579
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Mid-dose Bid BI 3731579
n=8 Participants
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
High-dose Bid BI 3731579
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Maximum Measured Concentration of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
1240 nanomole/liter
Geometric Coefficient of Variation 20.8
3320 nanomole/liter
Geometric Coefficient of Variation 36.1
8370 nanomole/liter
Geometric Coefficient of Variation 22.9
—

Adverse Events

Midazolam

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Placebo-matching BI 3731579

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Low-dose Bid BI 3731579

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Mid-dose Bid BI 3731579

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

High-dose Bid BI 3731579

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Midazolam
n=30 participants at risk
Healthy participants took, on Day 1, 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose.
Placebo-matching BI 3731579
n=6 participants at risk
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 17, participants took placebo-matching film-coated tablets of BI 3731579, orally, with 240 milliliters (mL) of water and 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. Midazolam was taken after placebo.
Low-dose Bid BI 3731579
n=8 participants at risk
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Mid-dose Bid BI 3731579
n=8 participants at risk
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
High-dose Bid BI 3731579
n=8 participants at risk
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. Midazolam was taken after BI 3731579.
Renal and urinary disorders
Urine odour abnormal
3.3%
1/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
50.0%
4/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Gastrointestinal disorders
Lip blister
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Gastrointestinal disorders
Tongue ulceration
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Infections and infestations
Upper respiratory tract infection
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
16.7%
1/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
25.0%
2/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Nervous system disorders
Headache
3.3%
1/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
16.7%
1/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
25.0%
2/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
25.0%
2/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Nervous system disorders
Paraesthesia
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
16.7%
1/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
General disorders
Medical device site rash
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Investigations
Electrocardiogram PR prolongation
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
Skin and subcutaneous tissue disorders
Skin odour abnormal
0.00%
0/30 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/6 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
12.5%
1/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.
0.00%
0/8 • Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.
Treated set (TS) - all participants who were treated with at least one dose of the trial drug. Adverse event reporting was presented based on study drug administration (placebo or BI 3731579), as defined in the statistical analysis plan.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

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