Clinical trial NCT03329209: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colitis, Ulcerative
Crohn Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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 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).

Primary outcomes:
measure: Cmax: Maximum Observed Serum Concentration for Vedolizumab
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
measure: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
measure: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Secondary outcomes:
measure: Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
measure: Percentage of Participants With Positive Neutralizing AVA
timeFrame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: