A Study to Test How Well Multiple Doses of BI 3810477 Are Tolerated by Healthy Adults

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: BI 3810477; Drug: Placebo

• Registration Number: NCT06984926
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 3810477 in healthy male and female trial participants when given as multiple rising doses.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Study Start: 2025-06-05
• Primary Completion: 2026-03-09
• Study Completion: 2026-03-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Healthy male and female participants 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), respiratory rate (RR), temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
• Age of 18 to 60 years (inclusive, to be checked at time of signing informed consent).
• 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.
• Further inclusion criteria apply.

Exclusion Criteria

• Any finding in the medical examination (including BP, PR, RR, temperature 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 3810477_dose group 1	BI 3810477	-
BI 3810477_dose group 4	BI 3810477	-
BI 3810477_dose group 2	BI 3810477	-
BI 3810477_dose group 3	BI 3810477	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Occurrence of any treatment-emergent adverse events assessed as drug-related by the investigator	Up to Day 117

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 3810477 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)	Up to Day 117
Maximum measured concentration of BI 3810477 in plasma at steady state (Cmax,ss)	Up to Day 117