Trial Outcomes & Findings for A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated (NCT NCT04537897)

Last Updated: 2024-03-08

Results Overview

Percentage of participants with drug-related adverse events is reported. Medical judgment were used to determine the relationship between study medication and the adverse events, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

70 participants

Primary outcome timeframe

For Midazolam: From first dose of midazolam (on Day -1) until first dose of BI 474121/Placebo, up to 1 day. Other groups: From first dose of BI 474121/Placebo until last dose+7 days of residual effect period, up to 21 days.

Results posted on

2024-03-08

Participant Flow

This trial investigated the safety, tolerability, and pharmacokinetics (PK) of BI 474121 in healthy male and female young and elderly subjects following oral administration of multiple rising doses per day over 14 days and to investigate the effect of BI 474121 on the PK of midazolam, given as an oral microdose.

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.

Participant milestones

Participant milestones
Measure	Placebo (Part A) Young participants administered matching placebo to 2.5 milligram (mg) and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) for placebo participants matched to 2.5mg BI, 10mg BI, 20mg BI, and 30mg BI groups.	BI 474121 2.5mg (Part A) Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).
Overall Study STARTED	10	8	8	8	8	8	4	8	8
Overall Study COMPLETED	10	7	8	7	8	8	3	8	8
Overall Study NOT COMPLETED	0	1	0	1	0	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 474121 2.5mg (Part A) Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).
Overall Study Other than listed	0	0	1
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (Part A) n=10 Participants Young participants administered matching placebo to 2.5 milligram (mg) and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) for placebo participants matched to 2.5mg BI, 10mg BI, 20mg BI, and 30mg BI groups.	BI 474121 2.5mg (Part A) n=8 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) n=8 Participants Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) n=4 Participants Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) n=8 Participants Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) n=8 Participants Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Total n=70 Participants Total of all reporting groups
Age, Continuous	28.0 Years STANDARD_DEVIATION 5.3 • n=99 Participants	35.4 Years STANDARD_DEVIATION 8.9 • n=107 Participants	31.4 Years STANDARD_DEVIATION 9.5 • n=206 Participants	31.3 Years STANDARD_DEVIATION 7.1 • n=7 Participants	32.4 Years STANDARD_DEVIATION 7.7 • n=31 Participants	29.3 Years STANDARD_DEVIATION 5.7 • n=30 Participants	66.5 Years STANDARD_DEVIATION 2.4 • n=3 Participants	70.8 Years STANDARD_DEVIATION 4.7 • n=6 Participants	72.3 Years STANDARD_DEVIATION 5.3 • n=114 Participants	42.4 Years STANDARD_DEVIATION 19.2
Sex: Female, Male Female	2 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants	3 Participants n=7 Participants	5 Participants n=31 Participants	5 Participants n=30 Participants	2 Participants n=3 Participants	1 Participants n=6 Participants	4 Participants n=114 Participants	29 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	5 Participants n=107 Participants	4 Participants n=206 Participants	5 Participants n=7 Participants	3 Participants n=31 Participants	3 Participants n=30 Participants	2 Participants n=3 Participants	7 Participants n=6 Participants	4 Participants n=114 Participants	41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=114 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=99 Participants	7 Participants n=107 Participants	8 Participants n=206 Participants	8 Participants n=7 Participants	8 Participants n=31 Participants	7 Participants n=30 Participants	4 Participants n=3 Participants	7 Participants n=6 Participants	8 Participants n=114 Participants	67 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	3 Participants
Race (NIH/OMB) White	8 Participants n=99 Participants	8 Participants n=107 Participants	7 Participants n=206 Participants	7 Participants n=7 Participants	8 Participants n=31 Participants	8 Participants n=30 Participants	4 Participants n=3 Participants	8 Participants n=6 Participants	8 Participants n=114 Participants	66 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants

PRIMARY outcome

Timeframe: For Midazolam: From first dose of midazolam (on Day -1) until first dose of BI 474121/Placebo, up to 1 day. Other groups: From first dose of BI 474121/Placebo until last dose+7 days of residual effect period, up to 21 days.

Population: Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=10 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) n=8 Participants Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) n=4 Participants Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) n=8 Participants Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) n=8 Participants Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam n=40 Participants 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Percentage of Participants With Drug-related Adverse Events	40.0 Percentage of participants	75.0 Percentage of participants	50.0 Percentage of participants	75.0 Percentage of participants	87.5 Percentage of participants	100.0 Percentage of participants	25.0 Percentage of participants	25.0 Percentage of participants	50.0 Percentage of participants	12.5 Percentage of participants

SECONDARY outcome

Timeframe: Within 1 hour (h) before and at 15 minutes (min), 30min, 1h, 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 23h45min after first dose of BI 474121.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.

The area under the concentration-time curve of BI 474121 in plasma from 0 to 24h (AUC0-24) after first dose is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=8 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=7 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) n=8 Participants Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) n=8 Participants Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Area Under the Concentration-time Curve of BI 474121 in Plasma From 0 to 24h (AUC0-24) After First Dose	230 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 20.9	486 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 23.1	862 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 19.1	1650 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 23.4	2430 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 20.0	410 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 34.2	891 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 13.7	—	—	—

SECONDARY outcome

Timeframe: Within 1 hour (h) before and at 15 minutes (min), 30min, 1h, 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 23h45min after first dose of BI 474121.

The maximum measured concentration of BI 474121 in plasma (Cmax) after first dose is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=8 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) n=8 Participants Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) n=8 Participants Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Maximum Measured Concentration of BI 474121 in Plasma (Cmax) After First Dose	22.6 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 29.7	43.9 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 19.8	82.4 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 25.9	167 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 33.2	229 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 20.2	44.3 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 37.7	89.4 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 15.0	—	—	—

SECONDARY outcome

Timeframe: Within 15 minutes (min) before and at 15 min, 30min, 1hour (h), 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h after administration of BI 474121 on Day 14.

The area under the concentration-time curve of BI 474121 in plasma at steady state over a uniform dosing interval τ (dosing interval = 24 hours) (AUCτ,ss) is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=7 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=7 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) n=8 Participants Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) n=8 Participants Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Area Under the Concentration-time Curve of BI 474121 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)	471 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 28.3	797 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 31.6	1280 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 25.1	2870 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 26.4	4350 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 27.4	764 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 39.4	1640 hour * nanomole / Liter (h*nmol/L) Geometric Coefficient of Variation 19.7	—	—	—

SECONDARY outcome

Timeframe: Within 15 minutes (min) before and at 15 min, 30min, 1hour (h), 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h after administration of BI 474121 on Day 14.

The maximum measured concentration of BI 474121 in plasma at steady state over a uniform dosing interval τ (dosing interval = 24 hours) (Cmax,ss) is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=7 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=7 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) n=8 Participants Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) n=8 Participants Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Maximum Measured Concentration of BI 474121 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)	40.1 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 26.3	67.8 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 22.2	113 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 19.6	249 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 23.9	385 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 26.8	60.6 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 40.0	142 nanomole / Liter (nmol/L) Geometric Coefficient of Variation 12.2	—	—	—

SECONDARY outcome

Timeframe: Within 1 hour (h) 30 minutes (min) before and at 15min, 30min, 1h, 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 23h after the administration of Midazolam on Day -1.

The maximum measured concentration of Midazolam in plasma (Cmax) on Day -1 is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=8 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Maximum Measured Concentration of Midazolam in Plasma (Cmax) - Day -1	980 picomole / Liter (pmol/L) Geometric Coefficient of Variation 34.8	747 picomole / Liter (pmol/L) Geometric Coefficient of Variation 20.2	1460 picomole / Liter (pmol/L) Geometric Coefficient of Variation 37.4	981 picomole / Liter (pmol/L) Geometric Coefficient of Variation 32.7	901 picomole / Liter (pmol/L) Geometric Coefficient of Variation 28.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 1 hour (h) before and at 15 minutes (min), 30min, 1h, 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 23h45min after administration of Midazolam on Day 1.

The Maximum measured concentration of Midazolam in plasma (Cmax) on Day 1 is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=8 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Maximum Measured Concentration of Midazolam in Plasma (Cmax) - Day 1	1090 picomole / Liter (pmol/L) Geometric Coefficient of Variation 44.7	913 picomole / Liter (pmol/L) Geometric Coefficient of Variation 35.2	1210 picomole / Liter (pmol/L) Geometric Coefficient of Variation 36.3	934 picomole / Liter (pmol/L) Geometric Coefficient of Variation 44.8	987 picomole / Liter (pmol/L) Geometric Coefficient of Variation 31.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 15 minutes (min) before and at 15min, 30min, 1hour (h), 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h after administration of Midazolam on Day 14.

The Maximum measured concentration of Midazolam in plasma (Cmax) on Day 14 is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=7 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=7 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Maximum Measured Concentration of Midazolam in Plasma (Cmax) - Day 14	1250 picomole / Liter (pmol/L) Geometric Coefficient of Variation 42.0	1010 picomole / Liter (pmol/L) Geometric Coefficient of Variation 28.2	1160 picomole / Liter (pmol/L) Geometric Coefficient of Variation 45.4	1090 picomole / Liter (pmol/L) Geometric Coefficient of Variation 51.9	931 picomole / Liter (pmol/L) Geometric Coefficient of Variation 31.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 1 hour (h) 30 minutes (min) before and at 15min, 30min, 1h, 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 23h after the administration of Midazolam on Day -1.

The area under the concentration-time curve of Midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) on Day -1 is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=8 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) - Day -1	2830 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 59.8	1920 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 27.2	3080 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 30.8	2610 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 56.9	2350 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 38.5	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 1 hour (h) before and at 15 minutes (min), 30min, 1h, 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 23h45min after administration of Midazolam on Day 1.

The Area under the concentration-time curve of Midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) on Day 1 is reported.

Outcome measures

Outcome measures
Measure	BI 474121 2.5mg (Part A) n=8 Participants Young participants administered 1 tablet of 2.5 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 5mg (Part A) n=8 Participants Young participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part A) n=8 Participants Young participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 20mg (Part A) n=8 Participants Young participants administered 2 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 20 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	BI 474121 30mg (Part A) Young participants administered 3 tablets of 10 milligrams (mg) BI 474121 orally once daily (daily dose: 30 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14). On Day -1, 1, and 14, 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h).	Placebo (Part B) Elderly participants administered matching placebo to 2.5 mg and 10 mg tablets once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 5mg (Part B) Elderly participants administered 2 tablets of 2.5 mg BI 474121 orally once daily (daily dose: 5 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	BI 474121 10mg (Part B) Elderly participants administered 1 tablet of 10 milligrams (mg) BI 474121 orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) over a treatment period of 14 days (Day 1 - Day 14).	Midazolam 75 micrograms (μg) of midazolam for injection used as oral solution were administered orally once daily with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) on Day -1 for young participants assigned to 2.5mg, 10,mg, 20mg, and 30mg BI/Placebo groups.
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) - Day 1	2760 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 58.3	2020 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 25.8	2720 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 31.4	2290 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 85.8	2360 hour * picomole / Liter (h * pmol/L) Geometric Coefficient of Variation 40.7	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 15 minutes (min) before and at 15min, 30min, 1hour (h), 1h30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h after administration of Midazolam on Day 14.

The Area under the concentration-time curve of Midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) on Day 14 is reported.