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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1015550; Drug: midazolam

• Registration Number: NCT05550636
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Study Start: 2022-10-11
• Status Verified: 2022-12
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Further exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BI 1015550 + midazolam treatment arm	midazolam	test and reference treatment arm
BI 1015550 + midazolam treatment arm	BI 1015550	test and reference treatment arm

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to Day 6
Maximum measured concentration of the analyte in plasma (Cmax)	Up to Day 6

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to Day 6

Trial Locations

Locations (1)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany