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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03329209

Enrollment

Registered

2017-11-01

Start date

2018-03-05

Completion date

2018-09-05

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative, Crohn Disease

Keywords

Drug therapy

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.

Interventions

DRUGVedolizumab

Vedolizumab intravenous infusion.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Participant flow

Recruitment details

Participants took part in the study at 1 investigative site in China from 05 March 2018 to 05 September 2018.

Pre-assignment details

Healthy Chinese participants were enrolled to receive a single dose of vedolizumab intravenous 300 milligram (mg).

Participants by arm

Arm	Count
Vedolizumab 300 mg Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1.	16
Total	16

Baseline characteristics

Characteristic	Vedolizumab 300 mg
Age, Continuous	30.4 years STANDARD_DEVIATION 6.22
Body Mass Index (BMI)	22.87 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.622
Height	167.00 centimeter (cm) STANDARD_DEVIATION 7.474
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	16 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment China	16 Participants
Sex: Female, Male Female	7 Participants
Sex: Female, Male Male	9 Participants
Weight	63.83 kilogram (kg) STANDARD_DEVIATION 6.448

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 16
other Total, other adverse events	6 / 16
serious Total, serious adverse events	0 / 16