Pain
Conditions
Keywords
Relative Bioavailability Effect of food
Brief summary
Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated
Interventions
DRUGPH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects aged 21 to 55 years * Healthy is defined as no clinical 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 * Willing to use acceptable methods of contraception as outlined in the study protocol * Body mass index between 18 to 30 kg/m2 * Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures
Exclusion criteria
* Subjects with evidence or history of clinically significant disease * Pregnant or nursing females * Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4 * Subjects with conditions possibly affecting drug absorption (eg gastrectomy) * A positive approved immunoassay/ELISA blood test for TB * Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men * Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication * Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of PH797804 up to 336 hours after dosing in each treatment period | 336 hours |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose | 336 hours |
Outcome results
None listed