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Completed

NCT Number: NCT05723874

A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood

The main objective of this trial is to investigate the relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral administration.

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Key information

Conditions

Healthy

Age range

30 year–55 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 30 to 55 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 mmHg, diastolic blood pressure outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse rate outside the range of 45 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

BI 425809

Drug

One daily film-coated tablet of 10 mg with 240 mL of water for 10 days (R) and for 14 days (T).

Other names: Iclepertin

Bosentan

Drug

Two daily film-coated tablets of 125 mg with 240 mL of water for 14 days (T).

Other names: Tracleer®

Primary outcomes

  1. Area Under the Concentration-time Curve of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)

    Time frame: Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description).

    Area under the concentration-time curve of BI 425809 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) is reported. The dosing interval τ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1.

  2. Maximum Measured Concentration of BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)

    Time frame: Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description).

    Maximum measured concentration of BI 425809 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) is reported. The dosing interval τ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1.

Secondary outcomes

  1. Minimum Concentration of BI 425809 in Plasma at Steady State Within a Uniform Dosing Interval τ (Cmin,ss)

    Time frame: Period 1: within 2 h before and 240 h after BI 425809 administration on Day 1 (for details, see description). Period 2: within 142 h and 335 h after BI 425809 and bosentan administration on Day 1 (for details, see description).

    Minimum concentration of BI 425809 in plasma at steady state within a uniform dosing interval τ (Cmin,ss) is reported. The dosing interval τ is 24 hours (h). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model. The ANOVA model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas 'treatment' was considered as fixed. Time frame period 1: within 2 h before and 192 h, 216 h, 216.5 h, 217 h, 217.5 h, 218 h, 218.5 h, 219 h, 219.5 h, 220 h, 220.5 h, 222 h, 224 h, 226 h, 228 h, 240 h after BI 425809 administration on Day 1. Time frame period 2: 142 h, 311 h, 311.5 h, 312 h, 312.5 h, 313 h, 313.5 h, 314 h, 314.5 h, 315 h, 315.5 h, 317 h, 319 h, 321 h, 323 h, 335 h after BI 425809 and bosentan administration on Day 1.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effect of Multiple Oral Doses of Bosentan on the Steady State Kinetics of BI 425809 After Oral Administration to Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Trial)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Mar 30, 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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