Testing how erythromycin affects BI 1291583 levels in healthy individuals

An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Erythromycin, a Moderate CYP3A4 Inhibitor, on the Pharmacokinetics of BI 1291583 at Steady State in Healthy Male and Female Subjects

This study tests how the antibiotic erythromycin affects the levels of a new drug, BI 1291583, in healthy adults aged 18 to 50.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Berlin)
• Trial ID: NCT06917872 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the impact of erythromycin, a moderate CYP3A4 inhibitor, on the pharmacokinetics of BI 1291583 in healthy participants. It involves administering both erythromycin and BI 1291583 to assess how erythromycin influences the concentration of BI 1291583 in the bloodstream. The study will include healthy male and female subjects aged 18 to 50, who meet specific health criteria. Participants will undergo thorough medical evaluations to ensure their eligibility.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 50 with a BMI between 18.5 and 29.9.

Not a fit: Patients with pre-existing health conditions or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of drug interactions, leading to safer and more effective medication regimens.

How similar studies have performed: While this specific approach is novel, studies on drug interactions involving CYP3A4 inhibitors have shown varying degrees of success.

Eligibility criteria

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

Where this trial is running

Berlin

• CRS Clinical Research Services Berlin GmbH — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy