Healthy VolunteersPhase 1NCT01408355
A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.
A Phase 1 study testing PF-06273588 in people with Healthy Volunteers, run by Pfizer at 1 site in United Kingdom.
Trial summary
To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-06273588
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Aug 2011
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week for males.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Pfizer Investigational Site
Ruddington Fields, Nottingham, NG11 6JS
About this study
Official title: An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects
To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.
- Conditions
- Healthy Volunteers
- Being tested
- PF-06273588
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06273588Drug
Intravenous, 50 microgram, single dose
PF-06273588Drug
Oral solution, 50 microgram, single dose
| Study group | Role | What they receive |
|---|---|---|
| 50 microgram PF-06273588 intravenous | Experimental | Subjects will receive a single intravenous microdose of PF-06273588 in period one Receives: Drug: PF-06273588 |
| 50 microgram PF-06273588 oral | Experimental | Subjects will receive a single oral microdose of PF-06273588 in period two Receives: Drug: PF-06273588 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with Adverse Events as a measure of Safety and tolerability.
Measured: 3 days
Pharmacokinetics : peak plasma concentration
Measured: 3 days
Pharmacokinetics : time of peak plasma concentration
Measured: 3 days
Pharmacokinetics : area under plasma concentration-time curve
Measured: 3 days
Pharmacokinetics : Terminal plasma half life
Measured: 3 days
Pharmacokinetics : Plasma Clearance
Measured: 3 days
Pharmacokinetics : plasma volume of distribution
Measured: 3 days
Pharmacokinetics : oral bioavailability
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT01408355
- Sponsor's protocol ID
- B4381001
- Status last verified
- Sep 2011
- First submitted
- 30 Jun 2011
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01408355
- Acronym / sponsor ID
- B4381001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Aug 2011 (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.
To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 microgram PF-06273588 intravenous | Experimental | Drug: PF-06273588Subjects will receive a single intravenous microdose of PF-06273588 in period one |
| 50 microgram PF-06273588 oral | Experimental | Drug: PF-06273588Subjects will receive a single oral microdose of PF-06273588 in period two |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week for males.
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-06273588Intravenous, 50 microgram, single dose | Drug | 50 microgram PF-06273588 intravenous |
| PF-06273588Oral solution, 50 microgram, single dose | Drug | 50 microgram PF-06273588 oral |
Primary outcome
The number of participants with Adverse Events as a measure of Safety and tolerability.
Time frame: 3 days
Pharmacokinetics : peak plasma concentration
Time frame: 3 days
Pharmacokinetics : time of peak plasma concentration
Time frame: 3 days
Pharmacokinetics : area under plasma concentration-time curve
Time frame: 3 days
Pharmacokinetics : Terminal plasma half life
Time frame: 3 days
Pharmacokinetics : Plasma Clearance
Time frame: 3 days
Pharmacokinetics : plasma volume of distribution
Time frame: 3 days
Pharmacokinetics : oral bioavailability
Time frame: 3 days
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 9 Sep 2011.
- 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 PF-06273588 in people with Healthy Volunteers, run by Pfizer at 1 site 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 2 inclusion and 3 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 9 Sep 2011. 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 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?
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?
The number of participants with Adverse Events as a measure of Safety and tolerability. (time frame: 3 days). The study lists 8 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 9 Sep 2011.