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
2 other identifiers
interventional
16
1 country
1
Brief Summary
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2018
CompletedResults Posted
Study results publicly available
September 6, 2019
CompletedSeptember 6, 2019
July 1, 2019
5 months
October 30, 2017
July 23, 2019
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cmax: Maximum Observed Serum Concentration for Vedolizumab
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Secondary Outcomes (2)
Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Percentage of Participants With Positive Neutralizing AVA
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Study Arms (1)
Vedolizumab 300 mg
EXPERIMENTALVedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 1, 2017
Study Start
March 5, 2018
Primary Completion
July 26, 2018
Study Completion
September 5, 2018
Last Updated
September 6, 2019
Results First Posted
September 6, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.