Clinical Trials/NCT06081530

NCT06081530

Completed

Phase 1

Single-blind, Randomised, Placebo-Controlled Trial on the Safety, Tolerability, and Pharmacokinetics of Single Rising Doses and Multiple Doses of Intravenous BI 3802876 in Healthy Subjects

Boehringer Ingelheim1 site in 1 country59 target enrollmentOctober 27, 2023

ConditionsHealthy

InterventionsBI 3802876 Placebo matching BI 3802876

DrugsBI 3802876 Placebo matching BI 3802876

Overview

Phase: Phase 1
Intervention: BI 3802876
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 59
Locations: 1
Primary Endpoint: Part A and Part B: Occurrences of any drug-related AEs between first drug administration (BI 3802876 or placebo) and end of the residual effect period (REP)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.

Registry

clinicaltrials.gov

Start Date

October 27, 2023

End Date

March 20, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram (ECG), and clinical laboratory tests
•Age of ≥18 to ≤55 years at screening
•Body mass index (BMI) of ≥ 19.0 to ≤ 28.0 kg/m2 at screening. A minimum body weight of 65 kg at screening
•Signed and dated written informed consent prior to admission to the study, in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion Criteria

•Any finding in the medical examination (including blood pressure (BP), pulse rate, or ECG) deviating from normal and assessed as clinically relevant by the investigator
•Three repeated measurements of systolic BP outside the range of 80 to 130 mm Hg, diastolic BP outside the range of 50 to 80 millimetre of mercury (mmHg), or pulse outside the range of 45 to 90 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

Arms & Interventions

Part A: BI 3802876 dose group 1

Intervention: BI 3802876

Part A: BI 3802876 dose group 2

Intervention: BI 3802876

Part A: BI 3802876 dose group 3

Intervention: BI 3802876

Part A: BI 3802876 dose group 4

Intervention: BI 3802876

Part A: BI 3802876 dose group 5

Intervention: BI 3802876

Part A: BI 3802876 dose group 6

Intervention: BI 3802876

Part A: Placebo

Intervention: Placebo matching BI 3802876

Part B: BI 3802876

Intervention: BI 3802876

Part B: Placebo

Intervention: Placebo matching BI 3802876

Outcomes

Primary Outcomes

Part A and Part B: Occurrences of any drug-related AEs between first drug administration (BI 3802876 or placebo) and end of the residual effect period (REP)

Time Frame: up to Day 35 for Part A and up to Day 117 for Part B

Secondary Outcomes

Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to Day 35)
Part B: Maximum measured concentration of the analyte in serum at steady state, if steady state can be reasonably assumed (Cmax,ss)(up to Day 117)
Part A: Maximum measured concentration of the analyte in serum (Cmax)(up to Day 35)
Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state, if steady state can be reasonably assumed (AUCτ,ss)(up to Day 117)