Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

Sponsor
Boehringer Ingelheim
Study ID
NCT03175211
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • BI 456906 — DRUG
    single dose
  • Placebo — DRUG
    single dose

Study Details

The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses. The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing

Key Dates

Start date
Jun 30, 2017
Status verified
Feb 2018
Primary completion
Feb 19, 2018
Completion
Feb 19, 2018

Study Design

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

Arms

  • Experimental: BI 456906
  • Placebo Comparator: Placebo

Primary Outcome Measure

[N (%)] of subjects with drug-related adverse events. [ Time Frame: Up to 672 hours ]

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