A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food

NCT ID: NCT05520827

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-29
• Study Completion Date: 2023-03-06

Brief Summary

Single Rising Dose (SRD) part:

The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses.

Food Effect (FE) part:

The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single Rising Dose part: BI 1584862

Group Type: EXPERIMENTAL

BI 1584862

Intervention Type: DRUG

BI 1584862

Single Rising Dose part: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Food effect part: BI 1584862 fed (treatment test, T)/ BI 1584862 fasted (treatment reference, R)

Group Type: EXPERIMENTAL

BI 1584862

Intervention Type: DRUG

BI 1584862

Food effect part: BI 1584862 fasted (treatment reference, R)/ BI 1584862 fed (treatment test, T)

Group Type: EXPERIMENTAL

BI 1584862

Intervention Type: DRUG

BI 1584862

Interventions

BI 1584862

BI 1584862

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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 45 years (inclusive).
• Body mass index (BMI)of 18.5 to 29.9 kg/m2 (inclusive).
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular liver enzymes (AST/ALT) above upper limit of normal and creatinine exceeding 1.2 mg/dl as confirmed by repeat measurements.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Countries

Germany

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

2022-001019-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1484-0001

Identifier Type: -

Identifier Source: org_study_id