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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

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ClinicalTrials.gov Identifier: NCT03961295
Recruitment Status : Completed
First Posted : May 23, 2019
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy Volunteers
Intervention Drug: Vedolizumab SC
Enrollment 24
Recruitment Details Participants took part in the study at 1 investigative site in the United states from 22 February 2018 to 28 August 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 prefilled syringe (PFS) or using an investigational device.
Arm/Group Title Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Hide Arm/Group Description Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1. Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device Total
Hide Arm/Group Description Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1. Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
37.2  (13.55) 33.6  (12.52) 35.4  (12.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
6
  50.0%
6
  50.0%
12
  50.0%
Male
6
  50.0%
6
  50.0%
12
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
1
   8.3%
1
   8.3%
2
   8.3%
Not Hispanic or Latino
11
  91.7%
11
  91.7%
22
  91.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
1
   8.3%
0
   0.0%
1
   4.2%
Asian
0
   0.0%
1
   8.3%
1
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   8.3%
3
  25.0%
4
  16.7%
White
10
  83.3%
7
  58.3%
17
  70.8%
More than one race
0
   0.0%
1
   8.3%
1
   4.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12
 100.0%
12
 100.0%
24
 100.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 12 participants 12 participants 24 participants
71.35  (11.614) 69.26  (10.637) 70.30  (10.944)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 12 participants 12 participants 24 participants
170.4  (10.08) 171.0  (7.94) 170.7  (8.88)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 12 participants 12 participants 24 participants
24.558  (3.2381) 23.603  (2.7232) 24.080  (2.9663)
1.Primary Outcome
Title AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable serum concentration.
Arm/Group Title Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Hide Arm/Group Description:
Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.
Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Overall Number of Participants Analyzed 12 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*day per milliliter(mcg*day/mL)
433.4
(38.3%)
560.3
(26.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A: Vedolizumab SC PFS, Group B: Vedolizumab SC Investigational Device
Comments Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LSMs
Estimated Value 1.2984
Confidence Interval (2-Sided) 90%
1.0786 to 1.5486
Estimation Comments [Not Specified]
2.Primary Outcome
Title AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK set included all participants who received study drug and had at least 1 measurable serum concentration.
Arm/Group Title Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Hide Arm/Group Description:
Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.
Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Overall Number of Participants Analyzed 12 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*day/mL
446.5
(36.2%)
594.0
(23.6%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A: Vedolizumab SC PFS, Group B: Vedolizumab SC Investigational Device
Comments Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LSMs
Estimated Value 1.3274
Confidence Interval (2-Sided) 90%
1.1147 to 1.5807
Estimation Comments [Not Specified]
3.Primary Outcome
Title Cmax: Maximum Observed Serum Concentration for Vedolizumab SC
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK set included all participants who received study drug and had at least 1 measurable serum concentration.
Arm/Group Title Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Hide Arm/Group Description:
Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1.
Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Overall Number of Participants Analyzed 12 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram per milliliter (mcg/mL)
13.70
(24.2%)
16.53
(26.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A: Vedolizumab SC PFS, Group B: Vedolizumab SC Investigational Device
Comments Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LSMs
Estimated Value 1.1978
Confidence Interval (2-Sided) 90%
1.0394 to 1.3804
Estimation Comments [Not Specified]
Time Frame Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than Day 127
Adverse Event Reporting Description At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Hide Arm/Group Description Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1. Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
All-Cause Mortality
Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   0/12 (0.00%) 
Infections and infestations     
Pneumonia  1  1/12 (8.33%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A: Vedolizumab SC PFS Group B: Vedolizumab SC Investigational Device
Affected / at Risk (%) Affected / at Risk (%)
Total   9/12 (75.00%)   6/12 (50.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/12 (0.00%)  1/12 (8.33%) 
Dyspepsia  1  1/12 (8.33%)  0/12 (0.00%) 
General disorders     
Injection site pain  1  6/12 (50.00%)  3/12 (25.00%) 
Injection site paraesthesia  1  1/12 (8.33%)  0/12 (0.00%) 
Infections and infestations     
Epididymitis  1  1/12 (8.33%)  0/12 (0.00%) 
Pneumonia  1  0/12 (0.00%)  1/12 (8.33%) 
Upper respiratory tract infection  1  2/12 (16.67%)  3/12 (25.00%) 
Urinary tract infection  1  0/12 (0.00%)  1/12 (8.33%) 
Vaginal infection  1  0/12 (0.00%)  1/12 (8.33%) 
Viral infection  1  0/12 (0.00%)  1/12 (8.33%) 
Vulvovaginal candidiasis  1  0/12 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  0/12 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Headache  1  1/12 (8.33%)  2/12 (16.67%) 
Paraesthesia  1  1/12 (8.33%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/12 (8.33%)  0/12 (0.00%) 
Sinus congestion  1  1/12 (8.33%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03961295     History of Changes
Other Study ID Numbers: VedolizumabSC-1021
U1111-1205-7156 ( Other Identifier: WHO )
First Submitted: May 22, 2019
First Posted: May 23, 2019
Results First Submitted: July 9, 2019
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019