Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers | Drug: Vedolizumab SC | Phase 1 |
The drug being tested in this study is called vedolizumab SC. The study will assess the PK, and variability of a vedolizumab SC in a PFS vs investigational device.
This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three administration sites: Abdomen, thigh, or arm. The study will enroll approximately 24 participants, including 4 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
All participants will receive a single dose of study drug on Day 1.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 196 days. Participants will be contacted by telephone on Day 168 after their last dose of study drug for a follow-up assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Phase 1, Open-Label, Randomized, Parallel Group Pilot Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Vedolizumab Administered in Prefilled Syringe Versus Prefilled Syringe in Autoinjector in Healthy Subjects |
Actual Study Start Date : | February 22, 2018 |
Actual Primary Completion Date : | July 14, 2018 |
Actual Study Completion Date : | August 28, 2018 |
Arm | Intervention/treatment |
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Active Comparator: Group A: Vedolizumab SC PFS
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
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Drug: Vedolizumab SC
Vedolizumab SC liquid.
Other Name: ENTYVIO, KYNTELES, MLN0002
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Experimental: Group B: Vedolizumab SC Investigational Device
Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
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Drug: Vedolizumab SC
Vedolizumab SC liquid.
Other Name: ENTYVIO, KYNTELES, MLN0002
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Weighs greater than (>) 50 kilogram (kg) and less than (<) 90 kg and has a body mass index (BMI) from 18 to 28 kilogram per square meter (kg/m^2), inclusive, at the time of informed consent.
Exclusion Criteria:
Has active or latent tuberculosis (TB) as evidenced by the following:
o A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, defined as:
Note: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
United States, Nebraska | |
Celerion | |
Lincoln, Nebraska, United States, 68502 |
Study Director: | Medical Director | Takeda |
Tracking Information | |||||
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First Submitted Date ICMJE | May 22, 2019 | ||||
First Posted Date ICMJE | May 23, 2019 | ||||
Results First Submitted Date ICMJE | July 9, 2019 | ||||
Results First Posted Date ICMJE | August 19, 2019 | ||||
Last Update Posted Date | November 13, 2019 | ||||
Actual Study Start Date ICMJE | February 22, 2018 | ||||
Actual Primary Completion Date | July 14, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants | ||||
Official Title ICMJE | A Phase 1, Open-Label, Randomized, Parallel Group Pilot Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Vedolizumab Administered in Prefilled Syringe Versus Prefilled Syringe in Autoinjector in Healthy Subjects | ||||
Brief Summary | The purpose of this study is to compare PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device. | ||||
Detailed Description |
The drug being tested in this study is called vedolizumab SC. The study will assess the PK, and variability of a vedolizumab SC in a PFS vs investigational device. This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three administration sites: Abdomen, thigh, or arm. The study will enroll approximately 24 participants, including 4 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
All participants will receive a single dose of study drug on Day 1. This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 196 days. Participants will be contacted by telephone on Day 168 after their last dose of study drug for a follow-up assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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Condition ICMJE | Healthy Volunteers | ||||
Intervention ICMJE | Drug: Vedolizumab SC
Vedolizumab SC liquid.
Other Name: ENTYVIO, KYNTELES, MLN0002
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
24 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | August 28, 2018 | ||||
Actual Primary Completion Date | July 14, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: 1. Weighs greater than (>) 50 kilogram (kg) and less than (<) 90 kg and has a body mass index (BMI) from 18 to 28 kilogram per square meter (kg/m^2), inclusive, at the time of informed consent. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03961295 | ||||
Other Study ID Numbers ICMJE | VedolizumabSC-1021 U1111-1205-7156 ( Other Identifier: WHO ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Takeda | ||||
Study Sponsor ICMJE | Takeda | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Takeda | ||||
Verification Date | October 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |