HealthyPhase 1NCT01165736
To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity
A Phase 1 study testing PF-05186462, PF-05089771 and PF-05150122 in people with Healthy, run by Pfizer at 1 site in United Kingdom.
Trial summary
The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study. 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
- What is being tested?
- PF-05186462, PF-05089771 and PF-05150122
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Aug 2010
- 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 50 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 measurement, 12-lead ECG and clinical laboratory tests)
- Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
Who cannot join
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
- History of febrile illness within 5 days prior to the first dose a positive urine drug screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects
The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.
- Conditions
- Healthy
- Being tested
- PF-05186462, PF-05089771, PF-05150122, PF-05241328
- Keywords
- pharmacokinetics, safety, tolerability, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05186462Drug
single intravenous infusion of 100 microgram
PF-05186462Drug
single oral administration of 100 microgram
PF-05089771Drug
single intravenous infusion of 100 microgram of PF-05089771
PF-05089771Drug
single oral administration of 100 microgram PF-05089771
PF-05150122Drug
single intravenous administration of 100 microgram PF-05150122
PF-05150122Drug
single oral administration of 100 microgram PF-05150122
PF-05241328Drug
single intravenous infusion of 100 microgram PF-05241328
PF-05241328Drug
single oral administration 100 microgram PF-05241328
| Study group | Role | What they receive |
|---|---|---|
| Intravenous: PF-05186462 | Active comparator | Not described Receives: Drug: PF-05186462 |
| Oral: PF-05186462 | Active comparator | Not described Receives: Drug: PF-05186462 |
| Intravenous: PF-05089771 | Active comparator | Not described Receives: Drug: PF-05089771 |
| Oral: PF-05089771 | Active comparator | Not described Receives: Drug: PF-05089771 |
| Intravenous: PF-05150122 | Active comparator | Not described Receives: Drug: PF-05150122 |
| Oral: PF-05150122 | Active comparator | Not described Receives: Drug: PF-05150122 |
| Intravenous: PF-05241328 | Active comparator | Not described Receives: Drug: PF-05241328 |
| Oral: PF-05241328 | Active comparator | Not described Receives: Drug: PF-05241328 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)
Measured: up to 3 days post dose
pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve
Measured: up to 3 days post dose
Secondary outcomes (1)
safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)
Measured: up to 3 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165736
- Sponsor's protocol ID
- B3071001
- Status last verified
- Aug 2010
- First submitted
- 16 Jul 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01165736
- Acronym / sponsor ID
- B3071001
- Conditions
- Healthy
- Keywords
- pharmacokinetics, safety, tolerability, Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 Jul 2010 (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 this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Intravenous: PF-05186462 | Active comparator | Drug: PF-05186462 |
| Oral: PF-05186462 | Active comparator | Drug: PF-05186462 |
| Intravenous: PF-05089771 | Active comparator | Drug: PF-05089771 |
| Oral: PF-05089771 | Active comparator | Drug: PF-05089771 |
| Intravenous: PF-05150122 | Active comparator | Drug: PF-05150122 |
| Oral: PF-05150122 | Active comparator | Drug: PF-05150122 |
| Intravenous: PF-05241328 | Active comparator | Drug: PF-05241328 |
| Oral: PF-05241328 | Active comparator | Drug: PF-05241328 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy male subjects between the ages of 18 and 50 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 measurement, 12-lead ECG and clinical laboratory tests)
- Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
- History of febrile illness within 5 days prior to the first dose a positive urine drug screen
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-05186462single intravenous infusion of 100 microgram | Drug | Intravenous: PF-05186462 |
| PF-05186462single oral administration of 100 microgram | Drug | Oral: PF-05186462 |
| PF-05089771single intravenous infusion of 100 microgram of PF-05089771 | Drug | Intravenous: PF-05089771 |
| PF-05089771single oral administration of 100 microgram PF-05089771 | Drug | Oral: PF-05089771 |
| PF-05150122single intravenous administration of 100 microgram PF-05150122 | Drug | Intravenous: PF-05150122 |
| PF-05150122single oral administration of 100 microgram PF-05150122 | Drug | Oral: PF-05150122 |
| PF-05241328single intravenous infusion of 100 microgram PF-05241328 | Drug | Intravenous: PF-05241328 |
| PF-05241328single oral administration 100 microgram PF-05241328 | Drug | Oral: PF-05241328 |
Primary outcome
Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)
Time frame: up to 3 days post dose
pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve
Time frame: up to 3 days post dose
1 secondary outcome
safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)
Time frame: up to 3 days post dose
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 24 Aug 2010.
- 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 PF-05186462, PF-05089771 and PF-05150122 in people with Healthy, 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 3 inclusion and 2 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 24 Aug 2010. 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?
Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry) (time frame: up to 3 days post dose). The study lists 2 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 24 Aug 2010.