A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body

Sponsor
Boehringer Ingelheim
Study ID
NCT07368569
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin hydrochloride — DRUG
    Metformin hydrochloride
  • BI 764198 — DRUG
    BI 764198

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 764198 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).

Key Dates

Start date
Feb 6, 2026
Status verified
Apr 2026
Primary completion
Mar 14, 2026
Completion
Mar 17, 2026

Study Design

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

Arms

  • Experimental: Reference - Treatment (R-T)
    This arm starts with the reference treatment (R), metformin hydrochloride, followed by a washout period, and then the test treatment (T), metformin hydrochloride and BI 764198.
  • Experimental: Treatment - Reference (T-R)
    This arm starts with the test treatment (T), metformin hydrochloride and BI 764198, followed by a washout period, and then the reference treatment (R), metformin hydrochloride.

Primary Outcome Measure

Metformin: Area under the concentration-time (AUC) curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) [ Time Frame: Up to 5 days ]

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