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Completed

NCT Number: NCT05833139

A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood

The main objective of this trial is to investigate the effect of multiple doses of the strong CYP3A inhibitor and recommended P-glycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of a single dose of zongertinib in plasma following oral administration.

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Key information

Conditions

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 International Council for Harmonisation-Good Clinical Practice (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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (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

Zongertinib

Drug

Zongertinib

Other names: BI 1810631, Hernexeos®

Itraconazole

Drug

Itraconazole

Other names: Sempera® Liquid

Primary outcomes

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

    Time frame: Within 3 hours (h) prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 47, 71, 119, 167 h for both periods, and additionally at 191, 215, 239, 263, and 287 h for period 2, after zongertinib administration.

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

  2. Maximum Measured Concentration of Zongertinib in Plasma (Cmax)

    Time frame: Within 3 hours (h) prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 47, 71, 119, 167 h for both periods, and additionally at 191, 215, 239, 263, and 287 h for period 2, after zongertinib administration.

    Maximum measured concentration of zongertinib in plasma (Cmax) is reported.

Secondary outcomes

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

    Time frame: Within 3 hours (h) prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 47, 71, 119, 167 h for both periods, and additionally at 191, 215, 239, 263, and 287 h for period 2, after zongertinib administration.

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Sep 22, 2025

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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