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

StatusTerminated
PhasePhase 1
Started

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Record History

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  1. Suspended trial terminated Show 4 more changesShow less
    • Sponsor's reason: Sponsor decision - hold following the evaluation of a safety event. No current sites in the US. to Sponsor decision - hold following the evaluation of a safety event. No current sites in the US.
    • Enrollment target: estimated 36 to confirmed 8
    • Primary and study completion dates changed from estimate of Nov 26, 2026 to Sep 23, 2026
    • Eligibility criteria expanded, about 10 words
  2. Recruitment suspended Sponsor's reason: Sponsor decision - hold following the evaluation of a safety event. No current sites in the US.
    • Site details revised
    v3
  3. Recruitment opened
    • Start date changed from estimate of Jul 15, 2026 to Jul 17, 2026
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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
(from sponsor)		 Healthy
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov