A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 690517 formulation 2; Drug: BI 690517 formulation 1; Drug: Probenecid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06647810

U1111-1307-2145 (Registry Identifier)

1378-0025

2024-513590-45-00 (Registry Identifier)

Details and patient eligibility

About

This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female 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 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
• Signed and dated written informed consent m accordance with International Conference of Harmonization-Good Clinical Practice (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 mmHg, or pulse rate outside the range of 45 to 90 bpm (beats per minute)
• 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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15 participants in 3 patient groups

BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2

Experimental group

Treatment:

Drug: Probenecid

Drug: BI 690517 formulation 1

Drug: BI 690517 formulation 2

BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1

Experimental group

Treatment:

Drug: Probenecid

Drug: BI 690517 formulation 1

Drug: BI 690517 formulation 2

Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2

Experimental group

Treatment:

Drug: Probenecid

Drug: BI 690517 formulation 1

Drug: BI 690517 formulation 2