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CompletedNCT02163421Updated Feb 1, 2017Results posted

Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration

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

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  • Vedolizumab Intravenous 300 mg
  • Vedolizumab Subcutaneous 54 mg
  • Vedolizumab Subcutaneous 108 mg
  • Vedolizumab Subcutaneous 160 mg

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.

02

Conditions studied

  • Healthy

Keywords

  • Drug therapy
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant, or when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  3. Is a healthy male or female adult of non-Japanese decent 18 to 60 years of age inclusive or of Japanese descent (born to Japanese parents and grandparents and has lived outside Japan for less than 5 years), 20 to 60 years of age inclusive, at the time of informed consent.
  4. Weighs at least 45 kg (99 lb) and have a body mass index (BMI) between 18.0 and 30.0 kg/m\^2 for non-Japanese participants or 18.0 and 28.0 kg/m\^2 for Japanese participants, inclusive at Screening.
  5. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for a minimum of 18 weeks after last dose.
  6. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use acceptable methods of contraception from signing of informed consent throughout the duration of the study and for a minimum of 18 weeks after last dose.

Exclusion criteria

Exclusion Criteria:

  1. Has received any investigational compound within 30 days prior to dosing of study medication or history of treatment with another monoclonal antibody within 6 months to dosing of study medication.
  2. Has received vedolizumab in a previous clinical study or as a therapeutic agent.
  3. Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  4. Has uncontrolled, clinically significant (CS) neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, that may impact the ability of the participant or potentially confound the study results.
  5. Has a known hypersensitivity to any component of the formulation of vedolizumab SC or vedolizumab IV.
  6. Has one or more positive responses on the progressive multifocal leukoencephalitis (PML) subjective symptom checklist at screening or before dosing on Day 1.
  7. Has a positive result for drugs of abuse or alcohol at Screening or Check- in (Day -1).
  8. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol for 48 hrs prior to Day -1 throughout confinement and for 48 hrs prior to each clinic visit and drugs throughout the study.
  9. Is pregnant or lactating or intends to become pregnant before, during, or within 18 weeks after the last dose in this study; or intends to donate ova during such time period.
  10. If male, the participant intends to donate sperm during the course of this study or for 18 weeks after the last dose in this study.
  11. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking vedolizumab, or a similar drug in the same class, or that might interfere with the conduct of this study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
  12. 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.
  13. Has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
  14. Participant is unable to attend all study days or comply with protocol requirements.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Vedolizumab SC 54 mg

    Vedolizumab SC, once on Day 1.

    Drug: Vedolizumab SC

  • Experimental
    Vedolizumab SC 108 mg

    Vedolizumab SC, once on Day 1.

    Drug: Vedolizumab SC

  • Experimental
    Vedolizumab SC 160 mg

    Vedolizumab SC, once on Day 1.

    Drug: Vedolizumab SC

  • Active comparator
    Vedolizumab IV 300 mg

    Vedolizumab IV, once on Day 1.

    Drug: Vedolizumab IV

Interventions

  • DrugVedolizumab SC

    Vedolizumab injection, for subcutaneous use (vedolizumab SC)

    Also known as: MLN0002SC

  • DrugVedolizumab IV

    Vedolizumab injection, for intravenous use (vedolizumab IV)

    Also known as: MLN0002SC

06

What researchers measure

Primary outcomes

  1. 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)

07

Results

Posted Feb 1, 2017

Participant flow

Participants took part in the study at 1 investigative site in the United Kingdom from 09 June 2014 to 16 January 2015.

Participant flow — Overall Study
MilestoneVedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mg
Started12121212
Completed12121212
Not completed0000

Outcome measures

PrimaryPopulation 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)
Reported as:
Number · percentage of drug
Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration
percentage of drugVedolizumab Subcutaneous
Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration0.751 (0.689 to 0.819)

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent other events
Showing 10 of 38
Most frequent other events
EventVedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mg
HeadacheNervous system disorders3/123/123/120/12
DizzinessNervous system disorders1/120/120/123/12
NasopharyngitisInfections and infestations2/122/122/123/12
PresyncopeNervous system disorders0/122/120/120/12
Oropharyngeal painRespiratory, thoracic and mediastinal disorders1/120/122/120/12
ConstipationGastrointestinal disorders0/121/120/120/12
Gastrooesophageal reflux diseaseGastrointestinal disorders0/121/120/120/12
NauseaGastrointestinal disorders0/120/121/120/12
ToothacheGastrointestinal disorders1/120/120/120/12
Injection site reactionGeneral disorders0/120/120/121/12

Baseline characteristics

Safety analysis set included all randomized participants who received study drug.

Age, Continuous
Age, Continuous(years)Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Mean33.9 ± 12.3041.0 ± 13.0631.1 ± 9.5935.2 ± 12.8935.3 ± 12.21
Gender
Gender(Participants)Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Female455519
Male877729
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Asian666624
White566623
Multiracial10001
Weight
Weight(kilogram (kg))Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Mean65.8 ± 13.8468.0 ± 12.9667.6 ± 13.4264.3 ± 14.5866.4 ± 13.35
Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram per square meter (kg/m^2))Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Mean21.8 ± 2.9023.0 ± 2.9822.8 ± 2.4422.0 ± 3.4122.4 ± 2.90
Smoking Classification
Smoking Classification(participants)Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Had Never Smoked8910633
Current Smoker312511
Ex-Smoker12014
Alcohol Classification
Alcohol Classification(participants)Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Had Never Drunk00112
Current Drinker1199938
Ex-Drinker13228
Female Reproductive Status
Female Reproductive Status(participants)Vedolizumab Intravenous 300 mgVedolizumab Subcutaneous 54 mgVedolizumab Subcutaneous 108 mgVedolizumab Subcutaneous 160 mgTotal
Postmenopausal Female01001
Female of Childbearing Potential445518
Not Applicable (Participant was Male)877729
08

Study locations

2 sites
  • London, NW10 7EW, United Kingdom
  • London, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02163421
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jun 13, 2014
Start date
Jun 2014
Primary completion
Dec 2014
Completion
Jan 2015
Results posted
Feb 1, 2017
Last update
Feb 1, 2017

Study contacts

Medical Director Clinical Science
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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