A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam

Sponsor
Boehringer Ingelheim
Study ID
NCT06327256
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BI 3000202 — DRUG
    BI 3000202
  • Placebo — DRUG
    Placebo-matching BI 3000202
  • Midazolam — DRUG
    Midazolam

Study Details

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.

Key Dates

Start date
Apr 9, 2024
Status verified
Nov 2024
Primary completion
Sep 27, 2024
Completion
Sep 27, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose group 1
    Group receiving placebo or dose 1 of BI 3000202
  • Experimental: Dose group 2
    Group receiving placebo or dose 2 of BI 3000202
  • Experimental: Dose group 3
    Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
  • Experimental: Dose group 4
    Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo

Primary Outcome Measure

Percentage of subjects with drug-related adverse events [ Time Frame: Up to day 20 ]

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