A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804
A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2014
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
First Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedDecember 20, 2013
December 1, 2013
3 months
August 14, 2013
December 19, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Area Under the Curve From Time Zero to Time 72 hours (AUC72)
Area under the plasma concentration time-curve from zero to 72 hours (AUC72)
0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Study Arms (6)
PH-797804 PARTICLE SIZE 9-11UM
EXPERIMENTALPH-797804 PARTICLE SIZE 9-11UM WITH SLS
EXPERIMENTALPH-797804 PARTICLE SIZE <= 20UM
EXPERIMENTALPH-797804 PARTICLE SIZE <= 20UM WITH SLS
EXPERIMENTALPH-797804 PARTICLE SIZE <= 5UM
EXPERIMENTALPH-797804 PARTICLE SIZE <= 5UM WITH SLS
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects and/or healthy female subjects of non-child bearing potential 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 14 drinks/week for males.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Interventions
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
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 16, 2013
Study Start
March 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 20, 2013
Record last verified: 2013-12