HealthyPhase 1NCT01637285
A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers
A Phase 1 study testing PF-04856883 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to further evaluate the PK characteristics of PF-04856883. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-04856883
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2013
- 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
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers
The purpose of the study is to further evaluate the PK characteristics of PF-04856883.
- Conditions
- Healthy
- Being tested
- PF-04856883
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04856883Biological
Dose A
PF-04856883Biological
Dose B
PF-04856883Biological
Dose C
PF-04856883Biological
Dose D
| Study group | Role | What they receive |
|---|---|---|
| PF-04856883 Treatment Arm 1 | Experimental | Not described Receives: Biological: PF-04856883 |
| PF-04856883 Treatment Arm 2 | Experimental | Not described Receives: Biological: PF-04856883 |
| PF-04856883 Treatment Arm 3 | Experimental | Not described Receives: Biological: PF-04856883 |
| PF-04856883 Treatment Arm 4 | Experimental | Not described Receives: Biological: PF-04856883 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2
Measured: 4 weeks
Secondary outcomes (5)
Number of subjects with AEs reported
Measured: 4 weeks
Number of subjects with abnormal physical examination findings
Measured: 4 weeks
Number of subjects with abnormal clinical laboratory results
Measured: 4 weeks
Number of subjects with abnormal ECGs
Measured: 4 weeks
Number of subjects with abnormal vital signs
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT01637285
- Sponsor's protocol ID
- B1111005
- Status last verified
- Jul 2015
- First submitted
- 26 Jun 2012
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01637285
- Acronym / sponsor ID
- B1111005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Jul 2012 (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 purpose of the study is to further evaluate the PK characteristics of PF-04856883.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-04856883 Treatment Arm 1 | Experimental | Biological: PF-04856883 |
| PF-04856883 Treatment Arm 2 | Experimental | Biological: PF-04856883 |
| PF-04856883 Treatment Arm 3 | Experimental | Biological: PF-04856883 |
| PF-04856883 Treatment Arm 4 | Experimental | Biological: PF-04856883 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PF-04856883Dose A | Biological | PF-04856883 Treatment Arm 1 |
| PF-04856883Dose B | Biological | PF-04856883 Treatment Arm 2 |
| PF-04856883Dose C | Biological | PF-04856883 Treatment Arm 3 |
| PF-04856883Dose D | Biological | PF-04856883 Treatment Arm 4 |
Primary outcome
PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2
Time frame: 4 weeks
5 secondary outcomes
Number of subjects with AEs reported
Time frame: 4 weeks
Number of subjects with abnormal physical examination findings
Time frame: 4 weeks
Number of subjects with abnormal clinical laboratory results
Time frame: 4 weeks
Number of subjects with abnormal ECGs
Time frame: 4 weeks
Number of subjects with abnormal vital signs
Time frame: 4 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 31 Jul 2015.
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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.
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 PF-04856883 in people with Healthy, 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 1 inclusion and 1 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 31 Jul 2015. 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?
PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2 (time frame: 4 weeks). 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 31 Jul 2015.