A Phase 1 interventional study of Vedolizumab SC and Vedolizumab IV in Healthy, sponsored by Takeda. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Takeda · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to determine its bioavailability, safety, and tolerability in the body with three varying doses of vedolizumab SC compared to people who are administered vedolizumab IV.
The study will enroll approximately 24 non-Japanese patients and 24 Japanese patients. Participants will be randomly assigned to one of the four treatment groups:
All participants will receive the treatment they are assigned on Day 1 of the study.
This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 196 days. Participants will make 10 visits to the clinic, including one 8 day period of confinement to the clinic, and will be contacted by telephone at Study Day 168 (+/-3), approximately 6 months after dose for a follow-up questionnaire.
Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vedolizumab SC, once on Day 1.
Drug: Vedolizumab SC
Vedolizumab SC, once on Day 1.
Drug: Vedolizumab SC
Vedolizumab SC, once on Day 1.
Drug: Vedolizumab SC
Vedolizumab IV, once on Day 1.
Drug: Vedolizumab IV
Vedolizumab injection, for subcutaneous use (vedolizumab SC)
Also known as: MLN0002SC
Vedolizumab injection, for intravenous use (vedolizumab IV)
Also known as: MLN0002SC
Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration
Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis.
Time frame: Day 1: predose and on multiple time points (up to Day 127)
Participants took part in the study at 1 investigative site in the United Kingdom from 09 June 2014 to 16 January 2015.
| Milestone | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg |
|---|---|---|---|---|
| Started | 12 | 12 | 12 | 12 |
| Completed | 12 | 12 | 12 | 12 |
| Not completed | 0 | 0 | 0 | 0 |
Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis.
| percentage of drug | Vedolizumab Subcutaneous |
|---|---|
| Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration | 0.751 (0.689 to 0.819) |
Collected over Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 168 days after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vedolizumab Intravenous 300 mg | — | 0/12 (0%) | 9/12 (75%) |
| Vedolizumab Subcutaneous 54 mg | — | 0/12 (0%) | 8/12 (66.7%) |
| Vedolizumab Subcutaneous 108 mg | — | 0/12 (0%) | 11/12 (91.7%) |
| Vedolizumab Subcutaneous 160 mg | — | 0/12 (0%) | 8/12 (66.7%) |
| Event | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg |
|---|---|---|---|---|
| HeadacheNervous system disorders | 3/12 | 3/12 | 3/12 | 0/12 |
| DizzinessNervous system disorders | 1/12 | 0/12 | 0/12 | 3/12 |
| NasopharyngitisInfections and infestations | 2/12 | 2/12 | 2/12 | 3/12 |
| PresyncopeNervous system disorders | 0/12 | 2/12 | 0/12 | 0/12 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/12 | 0/12 | 2/12 | 0/12 |
| ConstipationGastrointestinal disorders | 0/12 | 1/12 | 0/12 | 0/12 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/12 | 1/12 | 0/12 | 0/12 |
| NauseaGastrointestinal disorders | 0/12 | 0/12 | 1/12 | 0/12 |
| ToothacheGastrointestinal disorders | 1/12 | 0/12 | 0/12 | 0/12 |
| Injection site reactionGeneral disorders | 0/12 | 0/12 | 0/12 | 1/12 |
Safety analysis set included all randomized participants who received study drug.
| Age, Continuous(years) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Mean | 33.9 ± 12.30 | 41.0 ± 13.06 | 31.1 ± 9.59 | 35.2 ± 12.89 | 35.3 ± 12.21 |
| Gender(Participants) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Female | 4 | 5 | 5 | 5 | 19 |
| Male | 8 | 7 | 7 | 7 | 29 |
| Race/Ethnicity, Customized(participants) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Asian | 6 | 6 | 6 | 6 | 24 |
| White | 5 | 6 | 6 | 6 | 23 |
| Multiracial | 1 | 0 | 0 | 0 | 1 |
| Weight(kilogram (kg)) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Mean | 65.8 ± 13.84 | 68.0 ± 12.96 | 67.6 ± 13.42 | 64.3 ± 14.58 | 66.4 ± 13.35 |
| Body Mass Index (BMI)(kilogram per square meter (kg/m^2)) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Mean | 21.8 ± 2.90 | 23.0 ± 2.98 | 22.8 ± 2.44 | 22.0 ± 3.41 | 22.4 ± 2.90 |
| Smoking Classification(participants) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Had Never Smoked | 8 | 9 | 10 | 6 | 33 |
| Current Smoker | 3 | 1 | 2 | 5 | 11 |
| Ex-Smoker | 1 | 2 | 0 | 1 | 4 |
| Alcohol Classification(participants) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Had Never Drunk | 0 | 0 | 1 | 1 | 2 |
| Current Drinker | 11 | 9 | 9 | 9 | 38 |
| Ex-Drinker | 1 | 3 | 2 | 2 | 8 |
| Female Reproductive Status(participants) | Vedolizumab Intravenous 300 mg | Vedolizumab Subcutaneous 54 mg | Vedolizumab Subcutaneous 108 mg | Vedolizumab Subcutaneous 160 mg | Total |
|---|---|---|---|---|---|
| Postmenopausal Female | 0 | 1 | 0 | 0 | 1 |
| Female of Childbearing Potential | 4 | 4 | 5 | 5 | 18 |
| Not Applicable (Participant was Male) | 8 | 7 | 7 | 7 | 29 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Takeda