A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.
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
1 other identifier
interventional
5
1 country
1
Brief Summary
To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Jul 2011
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedSeptember 9, 2011
September 1, 2011
1 month
June 30, 2011
September 8, 2011
Conditions
Outcome Measures
Primary Outcomes (8)
The number of participants with Adverse Events as a measure of Safety and tolerability.
3 days
Pharmacokinetics : peak plasma concentration
3 days
Pharmacokinetics : time of peak plasma concentration
3 days
Pharmacokinetics : area under plasma concentration-time curve
3 days
Pharmacokinetics : Terminal plasma half life
3 days
Pharmacokinetics : Plasma Clearance
3 days
Pharmacokinetics : plasma volume of distribution
3 days
Pharmacokinetics : oral bioavailability
3 days
Study Arms (2)
50 microgram PF-06273588 intravenous
EXPERIMENTALSubjects will receive a single intravenous microdose of PF-06273588 in period one
50 microgram PF-06273588 oral
EXPERIMENTALSubjects will receive a single oral microdose of PF-06273588 in period two
Interventions
Eligibility Criteria
You may qualify if:
- 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).
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.
- History of regular alcohol consumption exceeding 21 drinks/week for males.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Ruddington Fields, Nottingham, NG11 6JS, United Kingdom
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2011
First Posted
August 3, 2011
Study Start
July 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
September 9, 2011
Record last verified: 2011-09