Healthy
Conditions
Brief summary
This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.
Interventions
DRUGPF-06372865
7.5 mg as 3 x 2.5 mg tablets 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 and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive * 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 * Screening supine blood pressure \> 140 mm Hg (systolic) or \>90 mm Hg (diastolic), following at least 5 minutes of supine rest. * Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Decay Half-Life (t1/2) | basline to 48 hours | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | basline to 48 hours | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Maximum Observed Plasma Concentration (Cmax) | basline to 48 hours | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | basline to 48 hours | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | basline to 48 hours | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Diastolic Blood Pressure | basline to 48 hours | Value at time T minus value at baseline. |
| Change from baseline in heart rate | basline to 48 hours | value at time T minus value at baseline |
| Change from Baseline in Systolic Blood Pressure | basline to 48 hours | Value at time T minus value at baseline. |
Countries
Belgium
Outcome results
None listed