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Clinical Trials in Germany / NCT07774325
Recruiting Phase 1

A Study in Healthy Men to Find Out How Blocking Certain Transport Proteins Affects the Amount of BI 3000202 in the Blood

NCT07774325 · tracked via the Priya Life Science Germany tracker
Phase
Phase 1
Started
2026-09-01
Last updated
2026-09-09

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

BI 3000202 →Ciclosporin →Itraconazole →

BI 3000202: BI 3000202

Ciclosporin: Ciclosporin

Itraconazole: Itraconazole

Study summary

The main objective of this trial is to investigate the effects of multiple doses of Itraconazole and multiple doses of Ciclosporin on the pharmacokinetics of BI 3000202 in plasma following a single oral dose in healthy male trial participants.

Eligibility

Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history, physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests 2. Age of 18 to 55 years (inclusive) 3. Body mass index of 18.5 to 29.9 kg/m² (inclusive). Additionally, a minimum body weight of at least 60 kg is required 4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice and local legislation prior to admission to the trial Exclusion Criteria: 1. Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator 2. 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 45 to 90 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Humanpharmakologisches Zentrum Biberach Biberach Germany Recruiting

More Boehringer Ingelheim trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07774325 on ClinicalTrials.gov ↗ ← All trials in Germany