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

NCT07368569 | Completed Phase 1

• 3 other identifiers: 1434-00052025-522432-14U1111-1322-9764
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Up to 5 days

Study Arms (2)

Reference - Treatment (R-T)

EXPERIMENTAL

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: Metformin hydrochloride; Drug: BI 764198

Treatment - Reference (T-R)

EXPERIMENTAL

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: Metformin hydrochloride; Drug: BI 764198

Interventions

Metformin hydrochloride DRUG

Metformin hydrochloride

Reference - Treatment (R-T); Treatment - Reference (T-R)

BI 764198 DRUG

BI 764198

Reference - Treatment (R-T); Treatment - Reference (T-R)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 26, 2026
• Study Start: February 6, 2026
• Primary Completion: March 14, 2026
• Study Completion: March 17, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)