Healthy volunteers test drug interaction in Early-Stage trial
NCT ID NCT06917872
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 1 trial studied how the antibiotic erythromycin changes the levels of a new drug called BI 1291583 in the body. Twenty healthy adults took both drugs to see if the antibiotic affects how the new drug is processed. The goal was to gather safety and dosing information, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 1291583 (verducatib) and erythromycin
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Apr 2025
- Finished
-
Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy male and 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 50 years (inclusive) * Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) * Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Male subject, willing to use male contraception (condom or sexual abstinence) and to refrain from sperm donation from time point of administration of trial medication until 90 days after last administration of trial medication, if their sexual partner is a woman of child-bearing potential (WOCBP) or Female subject who meets any of the following criteria for a highly effective contraception from at least 30 days prior to first administration of trial medication until 5 months after last administration of trial medication: * Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom in male partner * Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom in male partner * Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), plus condom in male partner * Sexually abstinent * Male sexual partner of the trial participant is vasectomized and received medical assessment of the surgical success of the vasectomy (documented absence of sperm) * Surgically sterilized (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion) * Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory) 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 BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (including but not limited to electrolyte disturbances, particularly hypokalemia and hypomagnesemia) * Any evidence of a concomitant disease assessed as clinically relevant by the Investigator * Any known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hormonal or immunological disorders (including any known relevant immunodeficiency) * 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 * History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CRS Clinical Research Services Berlin GmbH
Berlin, 13627, Germany
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