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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

Primary Purpose

Colitis, Ulcerative, Crohn Disease

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Vedolizumab

About this trial

This is an interventional other trial for Colitis, Ulcerative focused on measuring Drug therapy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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:

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).

Sites / Locations

Peking University First Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vedolizumab 300 mg

Arm Description

Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.

Outcomes

Primary Outcome Measures

Cmax: Maximum Observed Serum Concentration for Vedolizumab

AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab

AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab

Secondary Outcome Measures

Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)

Percentage of Participants With Positive Neutralizing AVA

Full Information

NCT ID

NCT03329209

First Posted

October 30, 2017

Last Updated

July 23, 2019

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT03329209

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 5, 2018 (Actual)

Primary Completion Date

July 26, 2018 (Actual)

Study Completion Date

September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colitis, Ulcerative, Crohn Disease

Keywords

Drug therapy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vedolizumab 300 mg

Arm Type

Experimental

Arm Description

Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.

Intervention Type

Drug

Intervention Name(s)

Vedolizumab

Intervention Description

Vedolizumab intravenous infusion.

Primary Outcome Measure Information:

Title

Cmax: Maximum Observed Serum Concentration for Vedolizumab

Time Frame