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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05723874
Collaborator
(none)
14
Enrollment
2
Arms
1.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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)
Anticipated Study Start Date :
Mar 7, 2023
Anticipated Primary Completion Date :
May 5, 2023
Anticipated Study Completion Date :
May 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Period 1 (Reference treatment (R)): BI 425809

Drug: BI 425809
BI 425809
Other Names:
  • iclepertin

    		•
    Experimental: Period 2 (Test treatment (T)): bosentan + BI 425809

    Drug: BI 425809
    BI 425809
    Other Names:
  • iclepertin

    • Drug: bosentan
    bosentan
    Other Names:
  • Tracleer®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) [On Day 10 of period 1 and on Day 14 of period 2.]

    2. Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [On Day 10 of period 1 and on Day 14 of period 2.]

    Secondary Outcome Measures

    1. Minimum concentration of the analyte in plasma at steady state within a uniform dosing interval τ (Cmin,ss) [On Day 10 of period 1 and on Day 14 of period 2.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT05723874
    Other Study ID Numbers:
    • 1346-0056
    • 2021-006676-17
    First Posted:
    Feb 13, 2023
    Last Update Posted:
    Feb 13, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bosentan
    BI 425809

    Study Results

    No Results Posted as of Feb 13, 2023