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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Midazolam; Drug: BI 3031185; Drug: Placebo matching BI 3031185; Drug: YAZ®

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Japan
  • Fukuoka, Fukuoka, Japan, 813-0017
    • Fukuoka Mirai Hospital
    • Contact: Boehringer Ingelheim; Phone Number: 05050508862; Email: nippon@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SD part: BI 3031185; SD = Single dose	Drug: BI 3031185; BI 3031185
Experimental: SD Part: Placebo matching BI 3031185	Drug: Placebo matching BI 3031185; Placebo matching BI 3031185
Experimental: MD part: Midazolam and BI 3031185; MD = Multiple doses	Drug: Midazolam; Midazolam; Other Names: Midafresa®; Drug: BI 3031185; BI 3031185
Experimental: MD Part: Midazolam and Placebo matching BI 3031185	Drug: Midazolam; Midazolam; Other Names: Midafresa®; Drug: Placebo matching BI 3031185; Placebo matching BI 3031185
Experimental: OC part: YAZ® and BI 3031185; OC = Oral contraceptives	Drug: BI 3031185; BI 3031185; Drug: YAZ®; YAZ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator	SD = Single dose	Up to 29 days
MD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator	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-∞)	OC = Oral contraceptives	Up to 29 days
OC part: Maximum measured concentration of the analyte in plasma (Cmax)		Up to 29 days

Secondary Outcome Measures

Outcome Measure	Time Frame
SD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 11 days
SD part: Maximum measured concentration of the analyte in plasma (Cmax)	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)	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)	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)	Up to 29 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Midazolam; drospirenone and ethinyl estradiol combination
• Other Study ID Numbers: 1516-0005; U1111-1331-6622 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No