Completed

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1819479 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1819479 (Open-label, Randomised, Two-way Crossover Design)

What is being tested

BI 1819479

+ Placebo

Drug

Who is being recruted

From 18 to 50 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1

Interventional

Study Start: May 2021

See protocol details

Summary

Principal SponsorBoehringer Ingelheim

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 26, 2021

Actual date on which the first participant was enrolled.

The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses. The main objective of the food effect part is to investigate the influence of food on the relative bioavailability of BI 1819479.

Official TitleSafety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1819479 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1819479 (Open-label, Randomised, Two-way Crossover Design)

NCT04801693

Principal SponsorBoehringer Ingelheim

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests

Age of 18 to 50 years (inclusive)

BMI of 18.5 to 29.9 kg/m2 (inclusive)

Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

8 exclusion criteria prevent from participating

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, in particular, hepatic parameters (ALT/AST) or renal parameters (creatinine) exceeding the ULN after repeated measurements

Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

single rising doses (SRD) part

Group II

Experimental

Food effect part

Group III

Experimental

Food effect part

Group IV

Placebo

Single rising doses (SRD) part

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CRS Clinical Research Services Mannheim GmbH

Mannheim, GermanyOpen CRS Clinical Research Services Mannheim GmbH in Google Maps

CompletedOne Study Center