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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT05258110
Collaborator
(none)
15
1
2
2.4
6.2

Study Details

Study Description

Brief Summary

In order to assess the potential impact of steady state BI 425809 on CYP3A clinically, the effect of BI 425809 on the midazolam pharmacokinetics will be evaluated. Midazolam is a recommended substrate of CYP3A4.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Multiple Oral Doses of BI 425809 on Metabolism of Midazolam Administered Orally in Healthy Male Subjects (Open-label, Two-period, One-sequence Trial)
Actual Study Start Date :
Mar 18, 2022
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reference (R): midazolam alone

First treatment period

Drug: midazolam
midazolam
Other Names:
  • Midazolam-ratiopharm® 2 mg/ml solution
  • Experimental: Test (T): midazolam + BI 425809

    Second treatment period

    Drug: midazolam
    midazolam
    Other Names:
  • Midazolam-ratiopharm® 2 mg/ml solution
  • Drug: BI 425809
    BI 425809

    Outcome Measures

    Primary Outcome Measures

    1. Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to 12 hours per each period]

    2. Maximum measured concentration of midazolam in plasma (Cmax) [up to 12 hours per each period]

    Secondary Outcome Measures

    1. Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [up to 12 hours per each period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 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 18 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

    Site City State Country Postal Code
    1 Humanpharmakologisches Zentrum Biberach Biberach Germany 88397

    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:
    NCT05258110
    Other Study ID Numbers:
    • 1346-0035
    • 2021-005585-17
    First Posted:
    Feb 28, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    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:

    Study Results

    No Results Posted as of Jun 3, 2022