Trial Outcomes & Findings for A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood (NCT NCT05258110)

Last Updated: 2026-03-30

Results Overview

Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).

Results posted on

2026-03-30

Participant Flow

This Phase I drug-drug interaction trial was performed as a non-randomised, open-label, two-period, crossover, one-sequence trial in order to investigate the effect of the offender drug iclepertin on the victim drug midazolam, based on an intra-subject comparison in healthy male subjects.

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

Participant milestones

Participant milestones
Measure	Midazolam Alone (Reference (R)) / Midazolam + Iclepertin (BI 425809) (Test (T)) All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). All participants were also orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2) and 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). There was a washout phase of at least 24 hours between the administration of midazolam in Period 1 and the first iclepertin administration in Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.
Period 1 STARTED	15
Period 1 COMPLETED	15
Period 1 NOT COMPLETED	0
Wash-out period STARTED	15
Wash-out period COMPLETED	14
Wash-out period NOT COMPLETED	1
Period 2 STARTED	14
Period 2 COMPLETED	12
Period 2 NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Midazolam Alone (Reference (R)) / Midazolam + Iclepertin (BI 425809) (Test (T)) All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). All participants were also orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2) and 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). There was a washout phase of at least 24 hours between the administration of midazolam in Period 1 and the first iclepertin administration in Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.
Wash-out period Covid-19 infection	1
Period 2 Adverse Event	2

Baseline Characteristics

A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Midazolam Alone (Reference (R)) / Midazolam + Iclepertin (BI 425809) (Test (T)) n=15 Participants All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). All participants were also orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2) and 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). There was a washout phase of at least 24 hours between the administration of midazolam in Period 1 and the first iclepertin administration in Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.
Age, Continuous	38.6 Years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male Female	0 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Plasma concentrations of midazolam were measured within 1 hour (h) before and at 30 minutes (min), 1h, 1h 30 min, 2h, 3h, 4h, 6h, 8h, 10h, and 12h after administration of midazolam alone or in combination with iclepertin (BI 425809).

Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set who provided at least one pharmacokinetics (PK) endpoint defined as primary or secondary and was not excluded due to protocol deviation relevant to evaluation of PK or due to PK non-evaluability.

Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.

Outcome measures

Outcome measures
Measure	Midazolam Alone (Reference Treatment (R)) n=15 Participants All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.	Iclepertin (BI 425809) + Midazolam (Test Treatment (T)) n=12 Participants All participants received 10 mg iclepertin orally once daily over 21 days (from Day -20 until Day 1 of Period 2). All participants were then orally administered 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	70 hoursnanomole/Liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.087	63 hoursnanomole/Liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.089

PRIMARY outcome

Maximum measured concentration of midazolam in plasma (Cmax) is presented.

Outcome measures

Outcome measures
Measure	Midazolam Alone (Reference Treatment (R)) n=15 Participants All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.	Iclepertin (BI 425809) + Midazolam (Test Treatment (T)) n=12 Participants All participants received 10 mg iclepertin orally once daily over 21 days (from Day -20 until Day 1 of Period 2). All participants were then orally administered 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.
Maximum Measured Concentration of Midazolam in Plasma (Cmax)	29 nanomole/Liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.094	25 nanomole/Liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.104

SECONDARY outcome

Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.

Outcome measures

Outcome measures
Measure	Midazolam Alone (Reference Treatment (R)) n=15 Participants All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.	Iclepertin (BI 425809) + Midazolam (Test Treatment (T)) n=12 Participants All participants received 10 mg iclepertin orally once daily over 21 days (from Day -20 until Day 1 of Period 2). All participants were then orally administered 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2 (test treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	76 hoursnanomole/Liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.093	67 hoursnanomole/Liter (hnmol/L) Standard Error NA Adjusted geometric standard error = 1.095

Adverse Events

Midazolam Alone (Reference Treatment (R))

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Iclepertin (BI 425809) Alone

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Iclepertin (BI 425809) + Midazolam

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Midazolam Alone (Reference Treatment (R)) n=15 participants at risk All participants were orally administered a single dose of 2 milligrams (mg) midazolam solution alone on Day 1 of Period 1 (reference treatment). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.	Iclepertin (BI 425809) Alone n=14 participants at risk All participants were orally administered one film-coated tablet of 10 mg iclepertin (BI 425809) once daily over 21 days (from Day -20 until Day 1 of Period 2). The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.	Iclepertin (BI 425809) + Midazolam n=12 participants at risk All participants were orally administered 2 mg midazolam oral solution concomitantly with a film-coated tablet of 10 mg iclepertin on Day 1 of Period 2. The treatments were to be given under fasting conditions with 240 milliLiter (mL) of water.
General disorders Pyrexia	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	14.3% 2/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
General disorders Fatigue	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Nervous system disorders Headache	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	14.3% 2/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Nervous system disorders Dizziness	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Nervous system disorders Paraesthesia	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Nervous system disorders Tremor	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Gastrointestinal disorders Dry mouth	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	8.3% 1/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Eye disorders Vision blurred	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.
Infections and infestations Pharyngitis	0.00% 0/15 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	7.1% 1/14 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.	0.00% 0/12 • For midazolam alone (R): From dosing until end of 12 hours (h) of residual effect period (REP) thereafter, up to 12h; for all-cause mortality (ACM): until end of 14 days (d) of follow-up, up to 14d + 12h. For iclepertin alone: From first dose at Day -20 of Period 2 (P2) until Day 1 of P2 + 11d of REP, up to 31d; for ACM: up to 14d + 31d. For midazolam + iclepertin (T): From Day 1 at P2 until end of 11d REP, up to 11d; for ACM: up to 14d + 11d. Treated set (TS): The TS included all subjects who were treated with at least one dose of trial drug. The TS was used for all safety analyses.

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