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

Sponsor
Boehringer Ingelheim
Study ID
NCT06081530
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 27, 2023
Status verified
Apr 2025
Primary completion
Mar 20, 2025
Completion
Mar 20, 2025

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: BI 3802876 dose group 1
  • Experimental: Part A: BI 3802876 dose group 2
  • Experimental: Part A: BI 3802876 dose group 3
  • Experimental: Part A: BI 3802876 dose group 4
  • Experimental: Part A: BI 3802876 dose group 5
  • Experimental: Part A: BI 3802876 dose group 6
  • Placebo Comparator: Part A: Placebo
  • Experimental: Part B: BI 3802876
  • Placebo Comparator: Part B: Placebo

Primary Outcome Measure

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 ]

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