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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
Sponsor: Boehringer Ingelheim
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
BI 3031185
BI 3031185
Placebo matching BI 3031185
Placebo matching BI 3031185
Midazolam
Midazolam
YAZ®
YAZ®
Locations (1)
Fukuoka Mirai Hospital
Fukuoka, Fukuoka, Japan