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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329209
• Other study ID #: Vedolizumab-1014
• Secondary ID: U1111-1197-3577
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2018
• Est. completion date: September 5, 2018

Study information

• Verified date: July 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 5, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease

Intervention

Drug:
• Vedolizumab
Vedolizumab intravenous infusion.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Serum Concentration for Vedolizumab		Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Primary	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
Primary	AUC8: 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	Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)		Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Secondary	Percentage of Participants With Positive Neutralizing AVA		Day 1 pre-dose and at multiple time points (up to Day 127) post-dose