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 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
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedAugust 15, 2011
August 1, 2011
3 months
September 29, 2010
August 12, 2011
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
14 days
Plasma pharmacokinetics
up to 72 hours post dose
Urine pharmacokinetics
up to 24 hours post dose
Urine Pharmacodynamics
up to 24 hours post dose
Study Arms (2)
Cohort 1
EXPERIMENTALSubjects will be assigned to receive either PF-05212372 or placebo in each period
Cohort 2
EXPERIMENTALSubjects will be assigned to receive either PF-05212372 or placebo in each period
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 29, 2010
First Posted
August 11, 2011
Study Start
September 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 15, 2011
Record last verified: 2011-08