Healthy Volunteers
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to compare the 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 compare the PK of a vedolizumab SC in a PFS to an 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 102 participants per group (a total of 204 participants), including 34 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: * Group A: Vedolizumab SC PFS * Group B: Vedolizumab SC Investigational Device 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.
Interventions
DRUGVedolizumab SC
Vedolizumab SC liquid.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Weighs greater than (\>) 50 kilogram (kg) and less than (\<) 90 kg or 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
1. Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, AMG 181) or anti-mucosal addressin cell adhesion molecule-1 (anti-MAdCAM-1) antibodies or rituximab. 2. Has 1 or more positive responses on the PML subjective symptom checklist at screening or before dosing on Day 1. 3. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year before the Screening Visit or is unwilling to agree to abstain from alcohol for 7 days before Day -1 throughout confinement and for 48 hours before each clinic visit; and drugs throughout the study. 4. Has evidence of an active infection during the Screening Period. 5. Has received any live vaccinations within 30 days before Screening. 6. 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: 1. Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR 2. A TB skin test reaction greater than or equal to (\>=) 5 millimeter (mm). NOTE: If participants have received Bacillus Calmette-Gueri (BCG) vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test. Note: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study. 7. Has poor peripheral venous access. 8. Is unable to attend all the study visits or comply with study procedures. 9. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including serum pheresis), or had a transfusion of any blood product within 45 days before Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC | 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 SC | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
| Cmax: Maximum Observed Serum Concentration for Vedolizumab SC | Day 1 pre-dose and at multiple time points (up to Day 127) post-dose |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United States from 12 March 2018 to 21 November 2018.
Pre-assignment details
Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using a prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
Participants by arm
| Arm | Count |
|---|---|
| Group A: Vedolizumab SC PFS Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1. | 102 |
| Group B: Vedolizumab SC Investigational Device Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1. | 102 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group A: Vedolizumab SC PFS | Group B: Vedolizumab SC Investigational Device | Total |
|---|---|---|---|
| Age, Continuous | 37.4 years STANDARD_DEVIATION 11.96 | 35.7 years STANDARD_DEVIATION 13.96 | 36.6 years STANDARD_DEVIATION 12.99 |
| Body mass index (BMI) | 24.727 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.3575 | 24.580 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.5635 | 24.653 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.4577 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 12 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 90 Participants | 184 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 173.8 centimeter (cm) STANDARD_DEVIATION 8.76 | 170.9 centimeter (cm) STANDARD_DEVIATION 9.78 | 172.3 centimeter (cm) STANDARD_DEVIATION 9.37 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants | 11 Participants | 25 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 77 Participants | 82 Participants | 159 Participants |
| Race/Ethnicity, Customized White, American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White, Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White, Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White, Native Hawaiian or Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 102 Participants | 102 Participants | 204 Participants |
| Sex: Female, Male Female | 42 Participants | 43 Participants | 85 Participants |
| Sex: Female, Male Male | 60 Participants | 59 Participants | 119 Participants |
| Weight | 73.93 kilogram (kg) STANDARD_DEVIATION 9.288 | 71.61 kilogram (kg) STANDARD_DEVIATION 9.971 | 72.77 kilogram (kg) STANDARD_DEVIATION 9.682 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 102 |
| other Total, other adverse events | 70 / 102 | 72 / 102 |
| serious Total, serious adverse events | 1 / 102 | 0 / 102 |
Outcome results
Primary
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Population: The PK set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vedolizumab SC PFS | AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC | 424.3 mcg*day/mL | Geometric Coefficient of Variation 35.6 |
| Group B: Vedolizumab SC Investigational Device | AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC | 479.8 mcg*day/mL | Geometric Coefficient of Variation 29.8 |
90% CI: [1.0169, 1.1521]
Primary
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Population: The pharmacokinetic (PK) set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vedolizumab SC PFS | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC | 402.8 microgram*day per milliliter(mcg*day/mL) | Geometric Coefficient of Variation 38.3 |
| Group B: Vedolizumab SC Investigational Device | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC | 452.3 microgram*day per milliliter(mcg*day/mL) | Geometric Coefficient of Variation 39 |
90% CI: [0.9963, 1.1565]
Primary
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Population: The PK set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group A: Vedolizumab SC PFS | Cmax: Maximum Observed Serum Concentration for Vedolizumab SC | 12.60 microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 29.1 |
| Group B: Vedolizumab SC Investigational Device | Cmax: Maximum Observed Serum Concentration for Vedolizumab SC | 13.66 microgram per milliliter (mcg/mL) | Geometric Coefficient of Variation 27.6 |
90% CI: [0.9935, 1.1023]