Colitis, UlcerativePhase 1NCT03329209
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
A Phase 1 study testing Vedolizumab in people with Colitis, Ulcerative and Crohn Disease, run by Takeda at 1 site in China.
Trial summary
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Colitis, Ulcerative, Crohn Disease
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2018to 5 Sep 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
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
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
Read the 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.
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Being tested
- Vedolizumab
- Keywords
- Drug therapy
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Vedolizumab intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab 300 mg | Experimental | Vedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1. Receives: Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Serum Concentration for Vedolizumab
Measured: 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
Measured: 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
Measured: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Secondary outcomes (2)
Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)
Measured: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Percentage of Participants With Positive Neutralizing AVA
Measured: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start5 Mar 2018
- Primary completion26 Jul 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329209
- Sponsor's protocol ID
- Vedolizumab-1014
- Other IDs
- U1111-1197-3577
- Status last verified
- Jul 2019
- First submitted
- 30 Oct 2017
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03329209
- Acronym / sponsor ID
- Vedolizumab-1014
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab 300 mg | Experimental | Drug: VedolizumabVedolizumab 300 mg, infusion, intravenously over 30-minutes, once on Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VedolizumabVedolizumab intravenous infusion. | Drug | Vedolizumab 300 mg |
Primary outcome
Cmax: Maximum Observed Serum Concentration for Vedolizumab
Time frame: 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
Time frame: 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
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
2 secondary outcomes
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
Percentage of Participants With Positive Neutralizing AVA
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vedolizumab in people with Colitis, Ulcerative and Crohn Disease, run by Takeda at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax: Maximum Observed Serum Concentration for Vedolizumab (time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.