Healthy VolunteersPhase 1NCT00788294
Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
A Phase 1 study testing tanezumab in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- tanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- BMI of 18-30 kg/m2
- more than 50 kg bodyweight.
Who cannot join
- Pregnant
- exposure to biologic type drugs within the last 3 months
- history of allergic or anaphylactic reaction to a biologic drug
- use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
- excessive alcohol use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Cypress, California, 90630
About this study
Official title: Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
- Conditions
- Healthy Volunteers
- Being tested
- tanezumab
- Keywords
- Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tanezumabBiological
Drug solution given intravenously only once at dose of 10 mg
tanezumabBiological
Drug solution given subcutaneously only once at dose of 5 mg.
tanezumabBiological
Drug solution given subcutaneously only once at dose of 10 mg.
tanezumabBiological
Drug solution given subcutaneously only once at dose of 19 mg.
| Study group | Role | What they receive |
|---|---|---|
| 10 mg IV | Active comparator | Not described Receives: Biological: tanezumab |
| 5 mg SC | Active comparator | Not described Receives: Biological: tanezumab |
| 10 mg SC | Active comparator | Not described Receives: Biological: tanezumab |
| 19 mg SC | Active comparator | Not described Receives: Biological: tanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous bioavailability
Measured: 16 weeks
Injection site reactions
Measured: 16 weeks
Immunogenicity
Measured: 16 weeks
Secondary outcomes (1)
Nerve growth factor levels
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788294
- Sponsor's protocol ID
- A4091013
- Status last verified
- Jul 2009
- First submitted
- 7 Nov 2008
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
- ClinicalTrials.gov ID
- NCT00788294
- Acronym / sponsor ID
- A4091013
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 mg IV | Active comparator | Biological: tanezumab |
| 5 mg SC | Active comparator | Biological: tanezumab |
| 10 mg SC | Active comparator | Biological: tanezumab |
| 19 mg SC | Active comparator | Biological: tanezumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy
- BMI of 18-30 kg/m2
- more than 50 kg bodyweight.
Key exclusion criteria (5 listed)
- Pregnant
- exposure to biologic type drugs within the last 3 months
- history of allergic or anaphylactic reaction to a biologic drug
- use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
- excessive alcohol use.
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 |
|---|---|---|
| tanezumabDrug solution given intravenously only once at dose of 10 mg | Biological | 10 mg IV |
| tanezumabDrug solution given subcutaneously only once at dose of 5 mg. | Biological | 5 mg SC |
| tanezumabDrug solution given subcutaneously only once at dose of 10 mg. | Biological | 10 mg SC |
| tanezumabDrug solution given subcutaneously only once at dose of 19 mg. | Biological | 19 mg SC |
Primary outcome
Subcutaneous bioavailability
Time frame: 16 weeks
Injection site reactions
Time frame: 16 weeks
Immunogenicity
Time frame: 16 weeks
1 secondary outcome
Nerve growth factor levels
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Screening Protocol
Pain
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tanezumab in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
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 3 inclusion and 5 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subcutaneous bioavailability (time frame: 16 weeks). The study lists 3 primary outcomes in all. 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 6 Oct 2020.