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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03329209 |
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Date of registration:
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30/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
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Scientific title:
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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 |
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Date of first enrolment:
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March 5, 2018 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03329209 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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 Criteria:
1. Has one or more positive response on the progressive multifocal leukoencephalopathy
(PML) subjective symptoms checklist at Screening or before dosing on Day 1.
2. 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).
3. 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.
4. Has poor peripheral venous access.
5. 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).
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colitis, Ulcerative
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Crohn Disease
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Intervention(s)
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Drug: Vedolizumab
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Primary Outcome(s)
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AUC8: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab
[Time Frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose]
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Cmax: Maximum Observed Serum Concentration for Vedolizumab
[Time Frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose]
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AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab
[Time Frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose]
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Secondary Outcome(s)
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Percentage of Participants With Positive Neutralizing AVA
[Time Frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose]
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Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)
[Time Frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose]
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Secondary ID(s)
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U1111-1197-3577
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Vedolizumab-1014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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