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NCT Number: NCT07774325

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Age of 18 to 55 years (inclusive)
  • Body mass index of 18.5 to 29.9 kg/m² (inclusive). Additionally, a minimum body weight of at least 60 kg is required
  • 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

  • Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
  • 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
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Further exclusion criteria apply.

Treatment and study plan

BI 3000202

Drug

BI 3000202

Ciclosporin

Drug

Ciclosporin

Itraconazole

Drug

Itraconazole

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: up to 4 days

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: up to 4 days

Secondary outcomes

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

    Time frame: up to 4 days

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

18002430127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effects of P-gp Inhibition and OATP Inhibition on the Pharmacokinetics of a Single Oral Dose of BI 3000202 in Healthy Male Trial Participants (an Open-label, Three-period, Two-sequence Crossover Trial, With Period 3 as Fixed Treatment)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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