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

NCT06655220 | Completed Phase 1

• 3 other identifiers: 1485-00132024-515911-23-00U1111-1306-9403
• 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 1815368 (Test, T) as compared to when metformin is administered as an oral multiple dose alone (Reference, R).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Up to 2 days after last dose administration

Study Arms (2)

Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test)

EXPERIMENTAL

Drug: Metformin hydrochloride; Drug: BI 1815368

Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference)

EXPERIMENTAL

Drug: Metformin hydrochloride; Drug: BI 1815368

Interventions

Metformin hydrochloride DRUG

Metformin hydrochloride

Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference); Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test)

BI 1815368 DRUG

BI 1815368

Metformin hydrochloride + BI 1815368 (Test) followed by metformin hydrochloride alone (reference); Metformin hydrochloride alone (reference) followed by metformin hydrochloride + BI 1815368 (Test)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age of 18 to 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• 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

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 mmHg, or pulse rate outside the range of 45 to 90 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
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

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

Model Details: Two-way crossover trial

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: November 8, 2024
• Primary Completion: December 8, 2024
• Study Completion: January 13, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)