NCT03329209

A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants

An Open-Label, Single-Center, Phase 1 Study to Determine the Pharmacokinetics of Single Intravenous Dose of Vedolizumab 300 mg in Healthy Adult Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.

Detailed description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis (UC) or Crohn's disease (CD). This study will look at the PK, safety, and tolerability of vedolizumab following a single intravenous infusion of vedolizumab IV in healthy adult Chinese participants. The study will enroll approximately 16 participants. All participants will be assigned to receive a single dose of vedolizumab IV 300 mg on Day 1. This single center trial will be conducted in China. The overall time to participate in this study is approximately 7 months. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after single dose of study drug for a follow-up safety survey assessment.

Conditions

• Colitis, Ulcerative
• Crohn Disease

Interventions

Type	Name	Description
DRUG	Vedolizumab	Vedolizumab intravenous infusion.

Timeline

• Start date: 2018-03-05
• Primary completion: 2018-07-26
• Completion: 2018-09-05
• First posted: 2017-11-01
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

1 site across 1 country: China