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A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

Primary Purpose

Healthy

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BI 456906
Microgynon®
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Otherwise healthy women 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 60 years (inclusive) Body mass index (BMI) of 27.0 to 40.0 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, i.e. prior to starting any screening procedures Subject fulfills any of the following criteria at least 4 weeks prior to allocation of subject number (i.e. prior to Day 1 of period 1): Use of non-hormone releasing intrauterine device (IUD) and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom Bilateral tubal ligation and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom Sexually abstinent (i.e. subjects must abstain from male-female sex) Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Postmenopausal, defined as no menses for 1 year without an alternative medical cause (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 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 of mercury (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 and/or liver enzymes (alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT)) and/or pancreatic enzymes (amylase lipase) above upper limit of normal range +10% at screening examination, confirmed by a repeat test Any evidence of a concomitant disease assessed as clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders History of either chronic or acute pancreatitis Cholecystectomy, and/or prior surgery of the gastrointestinal (GI) tract (including bariatric surgery) or any relevant anatomical malformation of the GI tract that could interfere with the pharmacokinetics of the trial medication (investigational medicinal product (IMP) or auxiliary medicinal product (AxMP)) - 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Microgynon® (Reference treatment (R)) followed by BI 456906 and Microgynon® (Test treatment (T))

    Arm Description

    Outcomes

    Primary Outcome Measures

    Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
    Maximum measured concentration of ethinylestradiol in plasma (Cmax)
    Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
    Maximum measured concentration of levonorgestrel in plasma (Cmax)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05896384
    Brief Title
    A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood
    Official Title
    A Non-randomised, Open-label Phase I Trial to Evaluate the Effect of BI 456906 at Different Dose Levels of Multiple Subcutaneous Doses in a Titration Scheme on the Single Dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Otherwise Healthy Women With Overweight/Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 4, 2023 (Anticipated)
    Primary Completion Date
    September 27, 2024 (Anticipated)
    Study Completion Date
    September 27, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is open to women with overweight or obesity who are otherwise healthy. Women with a body mass index (BMI) from 27 to 40 kg/m2 can participate. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of ethinylestradiol and levonorgestrel in the blood. Ethinylestradiol and levonorgestrel are ingredients of the contraceptive Microgynon®. The study has 2 treatment periods. In Period 1, participants get 1 tablet of Microgynon®. In Period 2, participants get weekly injections of BI 456906 for 7 months. The doses of BI 456906 increase each month. At 8 specific timepoints during Period 2, participants also get 1 tablet of Microgynon®. Participants visit the study site up to 40 times. At 8 visits, participants take Microgynon® and stay overnight at the site. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of ethinylestradiol and levonorgestrel in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Microgynon® (Reference treatment (R)) followed by BI 456906 and Microgynon® (Test treatment (T))
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BI 456906
    Intervention Description
    BI 456906
    Intervention Type
    Drug
    Intervention Name(s)
    Microgynon®
    Intervention Description
    Ethinylestradiol (EE) and Levonorgestrel (LNG)
    Primary Outcome Measure Information:
    Title
    Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
    Time Frame
    up to Week 29
    Title
    Maximum measured concentration of ethinylestradiol in plasma (Cmax)
    Time Frame
    up to Week 29
    Title
    Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
    Time Frame
    up to Week 29
    Title
    Maximum measured concentration of levonorgestrel in plasma (Cmax)
    Time Frame
    up to Week 29

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Otherwise healthy women 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 60 years (inclusive) Body mass index (BMI) of 27.0 to 40.0 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, i.e. prior to starting any screening procedures Subject fulfills any of the following criteria at least 4 weeks prior to allocation of subject number (i.e. prior to Day 1 of period 1): Use of non-hormone releasing intrauterine device (IUD) and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom Bilateral tubal ligation and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom Sexually abstinent (i.e. subjects must abstain from male-female sex) Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Postmenopausal, defined as no menses for 1 year without an alternative medical cause (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 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 of mercury (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 and/or liver enzymes (alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT)) and/or pancreatic enzymes (amylase lipase) above upper limit of normal range +10% at screening examination, confirmed by a repeat test Any evidence of a concomitant disease assessed as clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders History of either chronic or acute pancreatitis Cholecystectomy, and/or prior surgery of the gastrointestinal (GI) tract (including bariatric surgery) or any relevant anatomical malformation of the GI tract that could interfere with the pharmacokinetics of the trial medication (investigational medicinal product (IMP) or auxiliary medicinal product (AxMP)) - 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Boehringer Ingelheim
    Phone
    1-800-243-0127
    Email
    clintriage.rdg@boehringer-ingelheim.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
    Links:
    URL
    http://www.mystudywindow.com
    Description
    Related Info

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