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

Boehringer Ingelheim

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: BI 764198; Drug: Metformin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT07368569

U1111-1322-9764 (Registry Identifier)

1434-0005

2025-522432-14 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Reference - Treatment (R-T)

Experimental group

Description:

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.

Treatment:

Drug: Metformin hydrochloride

Drug: BI 764198

Treatment - Reference (T-R)

Experimental group

Description:

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.

Treatment:

Drug: Metformin hydrochloride

Drug: BI 764198