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A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04899674
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
2.1
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of a single dose of bupropion when given alone (Reference) compared with co-administration (Test) with BI 1358894 in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Two-period Fixed Sequence Trial to Evaluate the Effect of Multiple Doses of BI 1358894 on the Pharmacokinetics of Bupropion in Healthy Volunteers
Actual Study Start Date :
Jun 30, 2021
Actual Primary Completion Date :
Sep 2, 2021
Actual Study Completion Date :
Sep 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bupropion (Reference, R) - BI 1358894 + Bupropion (Test, T)

Drug: Elontril
Elontril
Other Names:
  • Bupropion hydrochloride

    • Drug: BI 1358894
    BI 1358894

    Outcome Measures

    Primary 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 26 days]

    2. Maximum measured concentration of the analyte in plasma (Cmax) [Up to 26 days]

    Secondary Outcome Measures

    1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUC0-∞) [Up to 26 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male or female 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 prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

    • Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

    • Sexually abstinent

    • Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, intrauterine device

    • A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

    • Surgically sterilised (including hysterectomy)

    • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

    Exclusion Criteria:

    • Any finding in the medical examination (including safety laboratory, 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 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 CRS Clinical Research Services Mannheim GmbH Mannheim Germany 68167

    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:
    NCT04899674
    Other Study ID Numbers:
    • 1402-0018
    • 2020-006052-40
    First Posted:
    May 24, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    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:
    Bupropion

    Study Results

    No Results Posted as of Sep 16, 2021