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A Study in Japanese Healthy Men to Test How Well Different Doses of BI 3031185 Are Tolerated and a Study in Japanese Healthy Women to Test Whether BI 3031185 Influences the Amount of a Contraceptive in the Blood

15. juni 2026 opdateret af: Boehringer Ingelheim

Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of BI 3031185 in Japanese Healthy Male Trial Participants (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Multiple Doses of BI 3031185 on Pharmacokinetics of a Single Dose of a Combination of Drospirenone and Ethinylestradiol (Oral Contraceptive) in Japanese Healthy Female Trial Participants (Non-randomised, Open-label, Fixed Sequence Design)

Single dose (SD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of single dose.

Multiple doses (MD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of multiple doses.

Oral contraceptives (OC) part: The main objective of this trial is to investigate the effect of multiple oral doses of BI 3031185 on pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) (YAZ®) in Japanese healthy female trial participants.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Japan
      • Fukuoka, Fukuoka, Japan, 813-0017

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion criteria:

  • Single dose (SD) and multiple doses (MD) part: Healthy male trial participant 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 Oral contraceptives (OC) part: Women of non-childbearing potential (WONCBP) who meet postmenopausal or surgically sterilised according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests

    • Postmenopausal, defined as no menses for 1 year without an alternative medical cause.
    • Surgically sterilised (including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
  • SD and MD part: Age of 18 to 45 years (inclusive) OC part: Age of 18 to 64 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with 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 139 mmHg, diastolic blood pressure outside the range of 40 to 89 mmHg, or pulse rate outside the range of 45 to 99 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 Further exclusion criteria apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SD part: BI 3031185
SD = Single dose
Medicin: BI 3031185
BI 3031185
Eksperimentel: SD Part: Placebo matching BI 3031185
Medicin: Placebo matching BI 3031185
Placebo matching BI 3031185
Eksperimentel: MD part: Midazolam and BI 3031185
MD = Multiple doses
Medicin: Midazolam
Midazolam
Andre navne:
  • Midafresa®
Medicin: BI 3031185
BI 3031185
Eksperimentel: MD Part: Midazolam and Placebo matching BI 3031185
Medicin: Midazolam
Midazolam
Andre navne:
  • Midafresa®
Medicin: Placebo matching BI 3031185
Placebo matching BI 3031185
Eksperimentel: OC part: YAZ® and BI 3031185
OC = Oral contraceptives
Medicin: BI 3031185
BI 3031185
Medicin: YAZ®
YAZ®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Tidsramme: Up to 29 days
SD = Single dose
Up to 29 days
MD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Tidsramme: Up to 47 days
MD = Multiple doses
Up to 47 days
OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Tidsramme: Up to 29 days
OC = Oral contraceptives
Up to 29 days
OC part: Maximum measured concentration of the analyte in plasma (Cmax)
Tidsramme: Up to 29 days
Up to 29 days

Sekundære resultatmål

Resultatmål
Tidsramme
SD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Tidsramme: Up to 11 days
Up to 11 days
SD part: Maximum measured concentration of the analyte in plasma (Cmax)
Tidsramme: Up to 11 days
Up to 11 days
MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Tidsramme: Up to 39 days
Up to 39 days
MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Tidsramme: Up to 39 days
Up to 39 days
OC part: 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)
Tidsramme: Up to 29 days
Up to 29 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

26. november 2026

Studieafslutning (Anslået)

26. november 2026

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1516-0005
  • U1111-1331-6622 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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