A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: Placebo matching BI 3804379; Drug: BI 3804379

• Registration Number: NCT06575400
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female subjects following administration of single rising doses and administration of multiple rising doses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-28
• Study Start: 2024-09-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-10-23
• Study Completion: 2025-10-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

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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 BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.

Further exclusion criteria apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SRD Part: Placebo matching BI 3804379	Placebo matching BI 3804379	-
SRD Part: BI 3804379	BI 3804379	SRD= Single rising dose
MRD Part: Placebo matching BI 3804379	Placebo matching BI 3804379	-
MRD Part: BI 3804379	BI 3804379	MRD=Multiple rising dose.

Primary Outcome Measures

Name	Time	Method
SRD part and MRD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator	Up to Day 84 for SRD part and up to Day 168 for MRD part.

Secondary Outcome Measures

Name	Time	Method
SRD part: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	Up to Day 84.
MRD part: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to Day 168.
SRD part: Cmax (maximum measured concentration of the analyte in plasma)	Up to Day 84.
MRD part: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to Day 168.

Trial Locations

Locations (1)

SGS Life Science Services - Clinical Research; 🇧🇪 Edegem, Belgium