Conditions: Healthy
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Vedolizumab SC, once on Day 1. arm 2: Vedolizumab SC, once on Day 1. arm 3: Vedolizumab SC, once on Day 1. arm 4: Vedolizumab IV, once on Day 1.

Interventions: intervention 1: Vedolizumab SC intervention 2: Vedolizumab IV
Intervention descriptions: intervention 1: Vedolizumab injection, for subcutaneous use (vedolizumab SC) intervention 2: Vedolizumab injection, for intravenous use (vedolizumab IV)

Protocol document: