Status:
COMPLETED
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
Lead Sponsor:
Takeda
Conditions:
Colitis, Ulcerative
Crohn Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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,...
Eligibility Criteria
Inclusion
- 1\. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m\^2) inclusive at Screening.
Exclusion
- Has one or more positive response on the progressive multifocal leukoencephalopathy (PML) subjective symptoms checklist at Screening or before dosing on Day 1.
- Has had a surgical procedure requiring general anesthesia within 30 days before the initial Screening Visit or is planning to undergo a surgery that requires general anesthesia during the study period (through Final Visit/Day 127).
- For participants who are negative for hepatitis B surface antigen (HBsAg) but are positive for either surface antibodies and/or core antibodies, hepatitis B virus Deoxyribonucleic Acid (DNA) polymerase chain reaction will be performed and any result that meets or exceeds detection sensitivity will be excluded.
- Has poor peripheral venous access.
- Has a QT interval with Fridericia correction method (QTcF) greater than (\>) 430 millisecond (ms) (males) or \>450 ms (females) or PR outside the range 120 to 220 ms, confirmed with 1 repeat testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1).
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03329209
Start Date
March 5 2018
End Date
September 5 2018
Last Update
September 6 2019
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034