Rheumatoid Arthritis
Conditions
Keywords
Pharmacokinetics Immediate Release Oral Suspension Controlled Release Formulation
Brief summary
This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.
Interventions
DRUGsuspension IR
50 mg IR suspension once daily for one day
DRUGCR 1
50 mg shorter release CR once daily for one day
DRUGCR 2
50 mg medium release CR once daily for one day
DRUGCR 3
longer release SR formulation once daily for one day
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female 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 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion. * An informed consent document signed and dated by the subject or a legally acceptable representative. * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening. * Any conHistory of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. * condition possibly affecting drug absorption (eg, gastrectomy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC. | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram | 1 month |
| Other safety parameters including: physical examination and vital signs. | 1 month |
| Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology. | 1 month |
Countries
United States
Outcome results
None listed