A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body

Sponsor
Boehringer Ingelheim
Study ID
NCT06655220
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin hydrochloride — DRUG
    Metformin hydrochloride
  • BI 1815368 — DRUG
    BI 1815368

Study Details

The main objective of this trial is to investigate the effect on the exposure of metformin in plasma when administered as an oral multiple dose together with multiple oral doses of BI 1815368 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).

Key Dates

Start date
Nov 8, 2024
Status verified
Mar 2025
Primary completion
Dec 8, 2024
Completion
Jan 13, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test)
  • Experimental: Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference)

Primary Outcome Measure

AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Up to 2 days after last dose administration ]

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