The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to determine its bioavailability, safety, and tolerability in the body with three varying doses of vedolizumab SC compared to people who are administered vedolizumab IV. The study will enroll approximately 24 non-Japanese patients and 24 Japanese patients. Participants will be randomly assigned to one of the four treatment groups: * Vedolizumab Intravenous 300 mg * Vedolizumab Subcutaneous 54 mg * Vedolizumab Subcutaneous 108 mg * Vedolizumab Subcutaneous 160 mg All participants will receive the treatment they are assigned on Day 1 of the study. This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 196 days. Participants will make 10 visits to the clinic, including one 8 day period of confinement to the clinic, and will be contacted by telephone at Study Day 168 (+/-3), approximately 6 months after dose for a follow-up questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Vedolizumab injection, for subcutaneous use (vedolizumab SC)
Vedolizumab injection, for intravenous use (vedolizumab IV)
Unnamed facility
London, United Kingdom
Unnamed facility
London, United Kingdom
Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration
Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis.
Time frame: Day 1: predose and on multiple time points (up to Day 127)
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