HealthyPhase 1NCT02163421
Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
A Phase 1 study testing Vedolizumab SC and Vedolizumab IV in people with Healthy, run by Takeda at 2 sites in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vedolizumab SC and Vedolizumab IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2014to Jan 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- 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.
- 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.
- 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.
- 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.
- 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.
Who cannot join
- 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.
- Has received vedolizumab in a previous clinical study or as a therapeutic agent.
- 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.
- 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.
- Has a known hypersensitivity to any component of the formulation of vedolizumab SC or vedolizumab IV.
- Has one or more positive responses on the progressive multifocal leukoencephalitis (PML) subjective symptom checklist at screening or before dosing on Day 1.
Show all 14Show fewer
- Has a positive result for drugs of abuse or alcohol at Screening or Check- in (Day -1).
- 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.
- 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.
- 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.
- 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.
- 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.
- Has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
- Participant is unable to attend all study days or comply with protocol requirements.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1, Open Label, Randomized, Parallel Group Study to Assess the Absolute Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
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.
- Conditions
- Healthy
- Being tested
- Vedolizumab SC, Vedolizumab IV
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab SCDrug
Also called MLN0002SC
Vedolizumab injection, for subcutaneous use (vedolizumab SC)
Vedolizumab IVDrug
Also called MLN0002SC
Vedolizumab injection, for intravenous use (vedolizumab IV)
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab SC 54 mg | Experimental | Vedolizumab SC, once on Day 1. Receives: Drug: Vedolizumab SC |
| Vedolizumab SC 108 mg | Experimental | Vedolizumab SC, once on Day 1. Receives: Drug: Vedolizumab SC |
| Vedolizumab SC 160 mg | Experimental | Vedolizumab SC, once on Day 1. Receives: Drug: Vedolizumab SC |
| Vedolizumab IV 300 mg | Active comparator | Vedolizumab IV, once on Day 1. Receives: Drug: Vedolizumab IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1: predose and on multiple time points (up to Day 127)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163421
- Sponsor's protocol ID
- MLN0002SC_101
- Other IDs
- 2014-000927-26, U1111-1152-6903, 14/LO/0466, 2014
- Status last verified
- Dec 2016
- First submitted
- 6 Jun 2014
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Parallel Group Study to Assess the Absolute Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
- ClinicalTrials.gov ID
- NCT02163421
- Acronym / sponsor ID
- MLN0002SC_101
- Conditions
- Healthy
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Posted 1 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab SC 54 mg | Experimental | Drug: Vedolizumab SCVedolizumab SC, once on Day 1. |
| Vedolizumab SC 108 mg | Experimental | Drug: Vedolizumab SCVedolizumab SC, once on Day 1. |
| Vedolizumab SC 160 mg | Experimental | Drug: Vedolizumab SCVedolizumab SC, once on Day 1. |
| Vedolizumab IV 300 mg | Active comparator | Drug: Vedolizumab IVVedolizumab IV, once on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- 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.
- 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.
- 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.
- 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.
Key exclusion criteria (14 listed)
- 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.
- Has received vedolizumab in a previous clinical study or as a therapeutic agent.
- 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.
- 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.
- Has a known hypersensitivity to any component of the formulation of vedolizumab SC or vedolizumab IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab SCAlso: MLN0002SCVedolizumab injection, for subcutaneous use (vedolizumab SC) | Drug | Vedolizumab SC 108 mg, Vedolizumab SC 160 mg, Vedolizumab SC 54 mg |
| Vedolizumab IVAlso: MLN0002SCVedolizumab injection, for intravenous use (vedolizumab IV) | Drug | Vedolizumab IV 300 mg |
Primary outcome
Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration
Time frame: Day 1: predose and on multiple time points (up to Day 127)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vedolizumab SC and Vedolizumab IV in people with Healthy, run by Takeda at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration (time frame: Day 1: predose and on multiple time points (up to Day 127)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.