Trial Outcomes & Findings for A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood (NCT NCT05550636)

Last Updated: 2025-12-01

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). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.

Results posted on

2025-12-01

Participant Flow

Open-label, two period fixed sequence design trial to investigate the induction effect of multiple oral doses of 18 milligram (mg) of BI 1015550 twice daily (bid) on the pharmacokinetics of a single oral dose of midazolam.

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 treatment if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Midazolam (R) / BI 1015550 + Midazolam (T) A single dose of 1 milliliter (mL) of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1. In period 2, one film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T). There was a washout period of at least 24 hours between the reference treatment (R) and the first BI 1015550 administration in the test treatment (T).
Period 1 (Reference treatment period) STARTED	15
Period 1 (Reference treatment period) COMPLETED	15
Period 1 (Reference treatment period) NOT COMPLETED	0
Period 2 (Test treatment period) STARTED	15
Period 2 (Test treatment period) COMPLETED	15
Period 2 (Test treatment period) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Midazolam (R) / BI 1015550 + Midazolam (T) n=15 Participants A single dose of 1 milliliter (mL) of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1. In period 2, one film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T). There was a washout period of at least 24 hours between the reference treatment (R) and the first BI 1015550 administration in the test treatment (T).
Age, Continuous	37.6 Years STANDARD_DEVIATION 11.4 • n=121 Participants
Sex: Female, Male Female	0 Participants n=121 Participants
Sex: Female, Male Male	15 Participants n=121 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=121 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=121 Participants
Race (NIH/OMB) Asian	0 Participants n=121 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants
Race (NIH/OMB) Black or African American	1 Participants n=121 Participants
Race (NIH/OMB) White	13 Participants n=121 Participants
Race (NIH/OMB) More than one race	0 Participants n=121 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants

PRIMARY outcome

Timeframe: Midazolam (R): Within 3 hours prior to midazolam administration and up to 24 hours after midazolam administration, in period 1. BI 101550 + midazolam (T): 313 hours prior and up to 24 hours after BI 1015550 + midazolam administration, in period 2.

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 defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.

Outcome measures

Outcome measures
Measure	Midazolam (R) n=15 Participants A single dose of 1 mL of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1.	BI 1015550 + Midazolam (T) n=15 Participants One film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T) in period 2.
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	75.1 Hours * nanomol per liter (h*nmol/L) Standard Error NA Adjusted geometric standard error (gSE) = 1.108	69.3 Hours * nanomol per liter (h*nmol/L) Standard Error NA Adjusted geometric standard error (gSE) = 1.108

PRIMARY outcome

Maximum measured concentration of midazolam in plasma (Cmax). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.

Outcome measures

Outcome measures
Measure	Midazolam (R) n=15 Participants A single dose of 1 mL of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1.	BI 1015550 + Midazolam (T) n=15 Participants One film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T) in period 2.
Maximum Measured Concentration of Midazolam in Plasma (Cmax)	28.0 Nanomol per Liter (nmol/L) Standard Error NA Adjusted geometric standard error (gSE) = 1.082	21.8 Nanomol per Liter (nmol/L) Standard Error NA Adjusted geometric standard error (gSE) = 1.082

SECONDARY outcome

Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Detailed timeframe: For midazolam (R): Within 3 hours prior to midazolam administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after midazolam administration in period 1. For BI + midazolam (T): 313 hours prior to administration of BI 1015550 + midazolam, at BI 1015550 + midazolam administration (0 hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours after administration of BI 1015550 + midazolam in period 2.

Outcome measures

Outcome measures
Measure	Midazolam (R) n=15 Participants A single dose of 1 mL of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1.	BI 1015550 + Midazolam (T) n=15 Participants One film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T) in period 2.
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	80.8 Hours * nanomol per liter (h*nmol/L) Standard Error NA Adjusted geometric standard error (gSE) = 1.115	72.6 Hours * nanomol per liter (h*nmol/L) Standard Error NA Adjusted geometric standard error (gSE) = 1.115

Adverse Events

Midazolam

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

BI 1015550

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

BI 101550 + Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Midazolam n=15 participants at risk A single dose of 1 mL of midazolam solution (2mg/mL) was administered orally on Day 1 as reference treatment (R ) in period 1.	BI 1015550 n=15 participants at risk One film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 in period 2.	BI 101550 + Midazolam n=15 participants at risk One film-coated tablet of 18 mg BI 1015550 was administered orally twice daily (bid) for 13 days (Day -13 to Day -1), and once daily (qd) on Day 1 together with a single dose of 1 mL oral solution of midazolam (2mg/mL) as test treatment (T) in period 2.
Gastrointestinal disorders Constipation	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	6.7% 1/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	13.3% 2/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.
Gastrointestinal disorders Flatulence	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	13.3% 2/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	20.0% 3/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.
Nervous system disorders Headache	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	13.3% 2/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.
Nervous system disorders Hyperaesthesia	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	6.7% 1/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.
Nervous system disorders Sciatica	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	6.7% 1/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.
Infections and infestations Nasopharyngitis	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	6.7% 1/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.	0.00% 0/15 • For Midazolam: At midazolam administration, plus 12 hours of residual effect period (REP), up to 12 hours. For BI 101550 and BI 101550 + Midazolam: From first drug administration until last drug administration, plus REP of 7 days, up to 21 days. Treated Set (TS): This set included all subjects who were treated with at least 1 dose of trial drug.

Additional Information

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Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review Prior to any Submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI´s intellectual property rights.
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