Phase 1Phase 1NCT01415102
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
A Phase 1 study testing PF-05212372 in people with Phase 1 and Single Dose, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase 1, Single Dose, Safety
- What is being tested?
- PF-05212372
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects. (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).
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.
- Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.
- Conditions
- Phase 1, Single Dose, Safety, Toleration, Pharmacokinetics
- Being tested
- PF-05212372, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05212372Drug
Inhaled. Dose Level 1: 50 ug
PF-05212372Drug
Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
PF-05212372Drug
Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
PF-05212372Drug
Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
PlaceboDrug
Inhaled
PF-05212372Drug
Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
PF-05212372Drug
Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
PF-05212372Drug
Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
PlaceboDrug
Inhaled
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects will be assigned to receive either PF-05212372 or placebo in each period Receives: Drug: PF-05212372; Drug: Placebo |
| Cohort 2 | Experimental | Subjects will be assigned to receive either PF-05212372 or placebo in each period Receives: Drug: PF-05212372; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 14 days
Plasma pharmacokinetics
Measured: up to 72 hours post dose
Urine pharmacokinetics
Measured: up to 24 hours post dose
Urine Pharmacodynamics
Measured: up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT01415102
- Sponsor's protocol ID
- B2031001
- Status last verified
- Aug 2011
- First submitted
- 29 Sep 2010
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01415102
- Acronym / sponsor ID
- B2031001
- Conditions
- Phase 1, Single Dose, Safety, Toleration, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 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.
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-05212372, Drug: PlaceboSubjects will be assigned to receive either PF-05212372 or placebo in each period |
| Cohort 2 | Experimental | Drug: PF-05212372, Drug: PlaceboSubjects will be assigned to receive either PF-05212372 or placebo in each period |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects. (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).
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.
- Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.
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-05212372Inhaled. Dose Level 1: 50 ug | Drug | Cohort 1 |
| PF-05212372Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose | Drug | Cohort 1 |
| PF-05212372Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose | Drug | Cohort 1 |
| PF-05212372Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose | Drug | Cohort 1 |
| PlaceboInhaled | Drug | Cohort 1 |
| PF-05212372Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose | Drug | Cohort 2 |
| PF-05212372Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose | Drug | Cohort 2 |
| PF-05212372Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose | Drug | Cohort 2 |
| PlaceboInhaled | Drug | Cohort 2 |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 14 days
Plasma pharmacokinetics
Time frame: up to 72 hours post dose
Urine pharmacokinetics
Time frame: up to 24 hours post dose
Urine Pharmacodynamics
Time frame: up to 24 hours 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 15 Aug 2011.
- 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-05212372 in people with Phase 1 and Single Dose, 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 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 15 Aug 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 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 14 days). The study lists 4 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 15 Aug 2011.