Clinical Trial

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

Not Yet Recruiting Phase 1
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.
Trial Details
NCT Number NCT07656792
Lead Sponsor Boehringer Ingelheim
Conditions Healthy
Enrollment 36 participants
Start Date 2026-07-15
Primary Completion 2026-11-26 (estimated)
Study Completion 2026-11-26 (estimated)
Updated on ClinicalTrials.gov 2026-06-18