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

Healthy Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1584862 in Healthy Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006598
• Other study ID #: 1484-0002
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2023
• Est. completion date: May 5, 2024

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 5, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1584862
BI 1584862
• Placebo matching BI 1584862
Placebo matching BI 1584862
• midazolam
midazolam

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator	expressed as the percentage of subjects treated with investigational drug who experience such an event	Up to 27 days
Secondary	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)		Up to 15 days
Secondary	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t (Cmax,ss)		Up to 15 days

External Links

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