A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated

NCT06081530 | Completed Phase 1

• 2 other identifiers: 1517-00012023-504538-23-00
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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)

  up to Day 35 for Part A and up to Day 117 for Part B

Secondary Outcomes (4)

• 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 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

• 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

Study Arms (9)

Part A: BI 3802876 dose group 1

EXPERIMENTAL

Drug: BI 3802876

Part A: BI 3802876 dose group 2

EXPERIMENTAL

Drug: BI 3802876

Part A: BI 3802876 dose group 3

EXPERIMENTAL

Drug: BI 3802876

Part A: BI 3802876 dose group 4

EXPERIMENTAL

Drug: BI 3802876

Part A: BI 3802876 dose group 5

EXPERIMENTAL

Drug: BI 3802876

Part A: BI 3802876 dose group 6

EXPERIMENTAL

Drug: BI 3802876

Part A: Placebo

PLACEBO COMPARATOR

Drug: Placebo matching BI 3802876

Part B: BI 3802876

EXPERIMENTAL

Drug: BI 3802876

Part B: Placebo

PLACEBO COMPARATOR

Drug: Placebo matching BI 3802876

Interventions

BI 3802876 DRUG

BI 3802876

Part A: BI 3802876 dose group 1; Part A: BI 3802876 dose group 2; Part A: BI 3802876 dose group 3; Part A: BI 3802876 dose group 4; Part A: BI 3802876 dose group 5; Part A: BI 3802876 dose group 6; Part B: BI 3802876

Placebo matching BI 3802876 DRUG

Placebo matching BI 3802876

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 55 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 (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 13, 2023
• Study Start: October 27, 2023
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)