Skip to main content
OpenTrials
Completed

NCT Number: NCT06041438

A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood

The main objective of this trial is to investigate the effect on the exposure of BI 1584862 in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as compared to BI 1584862 when given alone as oral single dose (Reference, R).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male 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-GCP and local legislation prior to admission to the trial

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 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
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • 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

Treatment and study plan

BI 1584862

Drug

One dose with 240 mL of water after an overnight fast of at least 10 h

Itraconazole

Drug

200 mg daily after an overnight fast of at least 9 h for several consecutive days

Primary outcomes

  1. Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 to 4 h before and up to 3 days after BI 1584862 administration.

    Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

    Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

  2. Maximum Measured Concentration of BI 1584862 in Plasma (Cmax)

    Time frame: Within 3 to 4 h before and up to 3 days after BI 1584862 administration.

    Maximum measured concentration of BI 1584862 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

Secondary outcomes

  1. Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: Within 3 to 4 h before and up to 3 days after BI 1584862 administration.

    Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

    Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1584862 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Design Study)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2023
Registry last updated
Jun 3, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.