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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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ClinicalTrials.gov Identifier: NCT03329209
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Crohn Disease Drug: Vedolizumab Phase 1

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 IV 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
Experimental: Vedolizumab 300 mg
Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.
Drug: Vedolizumab
Vedolizumab IV infusion




Primary Outcome Measures :
  1. Cmax: Maximum Observed Serum Concentration for Vedolizumab [ Time Frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose ]
  2. 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 ]
  3. AUC∞: 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 HBsAg but are positive for either surface antibodies and/or core antibodies, hepatitis B virus 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329209


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03329209     History of Changes
Other Study ID Numbers: Vedolizumab-1014
U1111-1197-3577 ( Registry Identifier: WHO )
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Vedolizumab
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Gastrointestinal Agents