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OpenTrials
Completed

NCT Number: NCT07368569

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

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).

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria apply.

Treatment and study plan

Metformin Hydrochloride

Drug

Metformin hydrochloride

BI 764198

Drug

BI 764198

Other names: Apecotrep

Primary outcomes

  1. 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

  2. Metformin: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)

    Time frame: Up to 5 days

Secondary outcomes

  1. Metformin: Renal clearance of the analyte from plasma at steady state (CL R,ss)

    Time frame: Up to 5 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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