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

NCT07656792 | Recruiting Phase 1

• 2 other identifiers: 1516-0005U1111-1331-6622
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (5)

SD part: BI 3031185

EXPERIMENTAL

SD = Single dose

Drug: BI 3031185

SD Part: Placebo matching BI 3031185

EXPERIMENTAL

Drug: Placebo matching BI 3031185

MD part: Midazolam and BI 3031185

EXPERIMENTAL

MD = Multiple doses

Drug: BI 3031185; Drug: Midazolam

MD Part: Midazolam and Placebo matching BI 3031185

EXPERIMENTAL

Drug: Placebo matching BI 3031185; Drug: Midazolam

OC part: YAZ® and BI 3031185

EXPERIMENTAL

OC = Oral contraceptives

Drug: BI 3031185; Drug: YAZ®

Interventions

BI 3031185 DRUG

BI 3031185

MD part: Midazolam and BI 3031185; OC part: YAZ® and BI 3031185; SD part: BI 3031185

Midazolam DRUG

Midazolam

Also known as: Midafresa®

MD Part: Midazolam and Placebo matching BI 3031185; MD part: Midazolam and BI 3031185

YAZ® DRUG

YAZ®

OC part: YAZ® and BI 3031185

Placebo matching BI 3031185 DRUG

Placebo matching BI 3031185

MD Part: Midazolam and Placebo matching BI 3031185; SD Part: Placebo matching BI 3031185

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Fukuoka Mirai Hospital

Fukuoka, Fukuoka, 813-0017, Japan

RECRUITING

Related Links

• Related Info

MeSH Terms

Interventions

Midazolam; drospirenone and ethinyl estradiol combination

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose part: Blinded to trial participants, randomized Multiple doses part: Blinded to trial participants, randomized Oral contraceptives part: No masking, non-randomized

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)