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)

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 764198; Drug: Metformin hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany, 88397
    • Humanpharmakologisches Zentrum Biberach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: BI 764198; BI 764198; Other Names: Apecotrep; Drug: Metformin hydrochloride; Metformin hydrochloride
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.	Drug: BI 764198; BI 764198; Other Names: Apecotrep; Drug: Metformin hydrochloride; Metformin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2026
• Primary Completion (Actual): March 14, 2026
• Study Completion (Actual): March 17, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin
• Other Study ID Numbers: 1434-0005; 2025-522432-14 (Registry Identifier: CTIS); U1111-1322-9764 (Registry Identifier: WHO Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No