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TERMINATED
NCT07656792
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-07-17

Completion Date

2026-09-23

Last Updated

2026-10-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BI 3031185

BI 3031185

DRUG

Placebo matching BI 3031185

Placebo matching BI 3031185

DRUG

Midazolam

Midazolam

DRUG

YAZ®

YAZ®

Locations (1)

Fukuoka Mirai Hospital

Fukuoka, Fukuoka, Japan