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drugset / Trial / NCT07656792

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 ↗

Phase 1 Not yet recruiting 36 enrolled Boehringer Ingelheim
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-07-15
Primary completion
2026-11-26
Completion
2026-11-26

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 3031185 Unknown — Oral
Subject YAZ® Unknown — —
Background Midazolam Small molecule — —

Indications

No indication recorded.