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

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorBoehringer Ingelheim

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BI 3000202
  • Ciclosporin
  • Itraconazole

Treatment groups

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators