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

Investigation of the Effect of BI 764198 on the Pharmacokinetics of Metformin Following Multiple Oral Administration in Healthy Male and Female Trial Participants (an Open-label, Randomised, Two-way Crossover Trial)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07368569

Enrollment

Registered

2026-01-26

Start date

2026-02-06

Completion date

2026-03-17

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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).

Interventions

DRUGMetformin hydrochloride

Metformin hydrochloride

DRUGBI 764198

BI 764198

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure \[BP\], Pulse rate \[PR\]), 12-lead Electrocardiogram (ECG), and clinical laboratory tests. * Age of 18 to 55 years (inclusive). * BMI of 18.5 to 29.9 kg / m² (inclusive). * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. * Further inclusion criteria apply.

Exclusion criteria

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. * Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 millimeters of mercury (mmHg), or pulse rate outside the range of 50 to 90 beat per minute (bpm). * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. * Any evidence of a concomitant disease assessed as clinically relevant by the investigator. * Further

Design outcomes

Primary

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

Secondary

Measure	Time frame
Metformin: Renal clearance of the analyte from plasma at steady state (CL R,ss)	Up to 5 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026