Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects

Sponsor
Boehringer Ingelheim
Study ID
NCT01608087
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
21 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • BI 695502 — DRUG
    BI 695502 single i.v. infusion
  • bevacizumab — DRUG
    bevacizumab single i.v. infusion
  • bevacizumab — DRUG
    bevacizumab single i.v. infusion

Study Details

This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.

Key Dates

First listed
May 30, 2012
Start date
May 1, 2012
Status verified
Oct 2019
Primary completion
Nov 1, 2012
Completion
Nov 1, 2012

Study Design

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

Arms

  • Experimental: BI 695502
    Subject to receive one intravenous (i.v.) infusion of BI 695502
  • Active Comparator: bevacizumab A
    Subject to receive one i.v. infusion of bevacizumab
  • Active Comparator: bevacizumab B
    Subject to receive one i.v. infusion of bevacizumab

Primary Outcome Measure

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞). [ Time Frame: Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion ]

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