A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body

Investigation of the Effect of BI 1815368 on the Pharmacokinetics of Metformin Following Multiple Oral Administration in Healthy Subjects (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 1815368 (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 1815368; 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:

1. Healthy male subjects 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
2. Age of 18 to 50 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with international conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts 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: Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test)	Drug: BI 1815368; BI 1815368; Drug: Metformin hydrochloride; Metformin hydrochloride
Experimental: Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference)	Drug: BI 1815368; BI 1815368; Drug: Metformin hydrochloride; Metformin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to 2 days after last dose administration
C max,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to 2 days after last dose administration

Secondary Outcome Measures

Outcome Measure	Time Frame
CL R,ss (renal clearance of the analyte from plasma at steady state)	Up to 2 days after last dose administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Actual): December 8, 2024
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: 1485-0013; 2024-515911-23-00 (Other Identifier: CTIS); U1111-1306-9403 (Other Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

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