HealthyPhase 1NCT01753791
Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults
A Phase 1 study testing 80 mg PF-06473871, 160 mg PF-06473871 and 320 mg PF-06473871 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults. 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?
- 80 mg PF-06473871, 160 mg PF-06473871 and 320 mg PF-06473871
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2012to Jun 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
- Healthy male and/or females between the ages of 18 and 55 years inclusive
Who cannot join
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Dose Expansion Of A Within-cohort, Randomized, Double-blind, Third-party Open, Placebo-controlled, Single-and Multiple-dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of Pf-06473871 In Normal Healthy Adults
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.
- Conditions
- Healthy
- Being tested
- 80 mg PF-06473871, 160 mg PF-06473871, 320 mg PF-06473871, 480 mg PF-06473871
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
80 mg PF-06473871Drug
80 mg of PF-06473871 or placebo
160 mg PF-06473871Drug
160 mg of PF-06473871 or placebo
320 mg PF-06473871Drug
320 mg of PF-06473871 or placebo
480 mg PF-06473871Drug
480 mg of PF-06473871 or placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: 80 mg PF-06473871 |
| Cohort 2 | Experimental | Not described Receives: Drug: 160 mg PF-06473871 |
| Cohort 3 | Experimental | Not described Receives: Drug: 320 mg PF-06473871 |
| Cohort 4 | Experimental | Not described Receives: Drug: 480 mg PF-06473871 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Measured: 6 weeks
ECGs
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Measured: 6 weeks
Blood pressure
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Measured: 6 weeks
pulse rate
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Measured: 6 weeks
Injection siter reaction
The number and percentage of subjects that experienced injection site reactions will be analyzed.
Measured: 6 weeks
number of subjects with adverse events
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Measured: 6 weeks
severity of adverse events
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Measured: 6 weeks
Secondary outcomes (3)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 6 weeks
Area under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measured: 6 weeks
Maximum Observed Plasma Concentration (Cmax)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT01753791
- Sponsor's protocol ID
- B5301002
- Other IDs
- 2012-003797-13
- Status last verified
- Sep 2014
- First submitted
- 20 Nov 2012
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose Expansion Of A Within-cohort, Randomized, Double-blind, Third-party Open, Placebo-controlled, Single-and Multiple-dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of Pf-06473871 In Normal Healthy Adults
- ClinicalTrials.gov ID
- NCT01753791
- Acronym / sponsor ID
- B5301002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Dec 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 evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 80 mg PF-06473871 |
| Cohort 2 | Experimental | Drug: 160 mg PF-06473871 |
| Cohort 3 | Experimental | Drug: 320 mg PF-06473871 |
| Cohort 4 | Experimental | Drug: 480 mg PF-06473871 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or females between the ages of 18 and 55 years inclusive
Key exclusion criteria (1 listed)
- Currently pregnant
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 |
|---|---|---|
| 80 mg PF-0647387180 mg of PF-06473871 or placebo | Drug | Cohort 1 |
| 160 mg PF-06473871160 mg of PF-06473871 or placebo | Drug | Cohort 2 |
| 320 mg PF-06473871320 mg of PF-06473871 or placebo | Drug | Cohort 3 |
| 480 mg PF-06473871480 mg of PF-06473871 or placebo | Drug | Cohort 4 |
Primary outcome
Incidence of Adverse events
Time frame: 6 weeks
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
ECGs
Time frame: 6 weeks
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Blood pressure
Time frame: 6 weeks
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
pulse rate
Time frame: 6 weeks
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
Injection siter reaction
Time frame: 6 weeks
The number and percentage of subjects that experienced injection site reactions will be analyzed.
number of subjects with adverse events
Time frame: 6 weeks
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
severity of adverse events
Time frame: 6 weeks
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
3 secondary outcomes
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 6 weeks
Area under the Concentration-Time Curve (AUC)
Time frame: 6 weeks
Maximum Observed Plasma Concentration (Cmax)
Time frame: 6 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 26 Sep 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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 80 mg PF-06473871, 160 mg PF-06473871 and 320 mg PF-06473871 in people with Healthy, run by Pfizer at 1 site in Belgium.
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 26 Sep 2014. 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 Belgium. 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?
Incidence of Adverse events (time frame: 6 weeks). The study lists 7 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 26 Sep 2014.