CompletedPhase 1

A Study in Healthy Men to Test if Different Formulations of BI 764198 With or Without Food Influence the Amount of BI 764198 in the Blood

Belgium28 participantsStarted 2021-01-15

Plain-language summary

BI 764198 is intended to be used in patients hospitalized for COVID-19 at risk of respiratory complications. The present trial will investigate the relative bioavailability of BI 764198 administered as capsules versus tablets in a first part, and the relative bioavailability and food effect of four oral formulations: the newly developed tablet formulation under fed and fasted conditions as well as suspension from capsules and suspension from tablets in a second part.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 50 years (inclusive) at screening * Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) at screening * Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation * Male subjects who meet any of the following criteria from first administration of trial medication until 30 days after trial completion: * Use of adequate contraception by the female partners, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea * Sexually abstinent * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom) Sperm donation is not allowed from first study drug administration until 30 days after trial completion. Exclusion Criteria: * Any finding in the medical examination (…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial has already been completed and only enrolled healthy volunteers to test how food and different formulations affect drug absorption — does that mean BI 764198 is still in very early development, and what does that tell us about how much safety and effectiveness data exists so far?
2Since this study was measuring how much BI 764198 gets into the bloodstream under different conditions, do the results give any useful insight into which formulation or dosing approach might eventually be used in patients with my condition?
3Given that this was a Phase 1 study in healthy men only, is there any ongoing or planned trial that would be relevant to my specific situation, and would it be worth looking into those next steps?
4Because the trial focused on pharmacokinetics — meaning how the drug moves through the body — rather than on treating a disease, what would you want to see in later-phase trials before considering BI 764198 as a potential option for me?
5Are there already established standard treatments I should be considering now, rather than waiting to see how BI 764198 progresses through further clinical development?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

Timeframe: up to 4 days per period

Part 1: Cmax (maximum measured concentration of the analyte in plasma)

Timeframe: up to 4 days per period

Part 2: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

Timeframe: up to 5 days per period

Part 2: Cmax (maximum measured concentration of the analyte in plasma)

Timeframe: up to 5 days per period

Trial details

NCT IDNCT04656288

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-15

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

Timeframe: up to 4 days per period

Part 1: Cmax (maximum measured concentration of the analyte in plasma)

Timeframe: up to 4 days per period

Part 2: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

Timeframe: up to 5 days per period

Part 2: Cmax (maximum measured concentration of the analyte in plasma)

Timeframe: up to 5 days per period