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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05833139
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
1.9
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the effect of multiple doses of the strong CYP3A inhibitor and recommended Pglycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of a single dose of BI 1810631 in plasma following oral administration.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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)
Actual Study Start Date :
Apr 14, 2023
Anticipated Primary Completion Date :
Jun 12, 2023
Anticipated Study Completion Date :
Jun 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 1810631 (R) followed by BI 1810631 + itraconazole (T)

Drug: BI 1810631
BI 1810631

Drug: Itraconazole
Itraconazole
Other Names:
  • Sempera® Liquid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [up to 13 days]

    2. Maximum measured concentration of the analyte in plasma (Cmax) [up to 13 days]

    Secondary Outcome Measures

    1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to 13 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 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 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.

    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:
    NCT05833139
    Other Study ID Numbers:
    • 1479-0004
    • 2022-003757-63
    First Posted:
    Apr 27, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 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:
    Itraconazole

    Study Results

    No Results Posted as of May 1, 2023