Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532
An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of \[14C\]PF-04991532 in healthy adult male subjects.
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
Started Nov 2011
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
October 28, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 10, 2011
CompletedJanuary 31, 2012
January 1, 2012
Same day
October 28, 2011
January 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
0-168 hrs
Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces.
0-168 hrs
radioactivity AUC
0-168 hrs
plasma PF-04991532 AUC
0-168 hrs
radioactivity Cmax
0-168 hrs
plasma PF-04991532 Cmax
0-168 hrs
plasma PF-04991532 Tmax
0-168 hrs
radioactivity Tmax
0-168 hrs
plasma PF-04991532 t1/2
0-168 hrs
radioactivity t1/2
0-168 hrs
Study Arms (1)
1
EXPERIMENTALInterventions
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 measurement, 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).
- An informed consent document signed and dated by the subject.
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) or clinical findings at Screening.
- History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).
- Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Tacoma, Washington, 98418, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2011
First Posted
November 10, 2011
Study Start
November 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
January 31, 2012
Record last verified: 2012-01