Healthy
Conditions
Brief summary
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804
Interventions
DRUGPH-797804
Tablet, 6 mg, single dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Time 72 hours (AUC72) | 0,2,3,4,5,6,8,12,24,48,72 hours post-dose | Area under the plasma concentration time-curve from zero to 72 hours (AUC72) |
| 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 | — |
Outcome results
None listed