CompletedPhase 1

A Study in Healthy People to Test if Taking Different Formulations of BI 425809 Tablets Influences the Amount of BI 425809 in the Blood

Germany18 participantsStarted 2019-02-11

Plain-language summary

The main objective of this trial is to investigate the relative bioavailability of batch 1 of the intended commercial tablet formulation (iCF1) of BI 425809 vs batch 2 of the intended commercial tablet formulation (iCF2) of BI 425809 vs BI 425809 (TF2) formulation.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

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 or female 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 55 years (inclusive) * Body Mass Index (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 * Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion: * Use of adequate contraception, e.g. any of the following methods plus condom: \--- implants, injectables, combined oral or vaginal contraceptives, intrauterine device * Sexually abstinent * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) * Surgically sterilised (including hysterectomy) * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory) Exclusion Criteria: * Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range …

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)

Timeframe: within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.

Maximum Measured Concentration of BI 425809 in Plasma (Cmax)

Timeframe: within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.

Trial details

NCT IDNCT03817476

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-28

Results submitted2026-03-10

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

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

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)

Timeframe: within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.

Maximum Measured Concentration of BI 425809 in Plasma (Cmax)

Timeframe: within 3 hours before and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hours after drug administration.