A Study to Test How Well Different Doses of BI 1584862 Are Tolerated by Healthy Men

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1584862; Drug: Placebo matching BI 1584862; Drug: midazolam

• Registration Number: NCT06006598
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 1584862 in healthy male subjects following administration of multiple rising doses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2023-08-28
• Status Verified: 2024-05
• Primary Completion: 2024-05-05
• Study Completion: 2024-05-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. 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
2. Age of 18 to 50 years (inclusive)
3. Body mass indey (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1584862 treatment arm	BI 1584862	-
Placebo arm	Placebo matching BI 1584862	-
BI 1584862 + midazolam treatment arm	midazolam	-

Primary Outcome Measures

Name	Time	Method
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator	Up to 27 days	expressed as the percentage of subjects treated with investigational drug who experience such an event

Secondary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)	Up to 15 days
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)	Up to 15 days

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany