A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers
- Registration Number
- NCT01265732
- Lead Sponsor
- Pfizer
- Brief Summary
This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when respectively given orally as a single dispersion dose and a single dose of a suspension. The suspension is the test formulation and the dispersion is the formulation with which the novel preparation will be compared.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy male and/or female subjects of non-childbearing 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 measurement, 12-lead ECG or 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 the time of dosing).
- Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year. Subjects with AST or ALT >ULN. Subjects with total bilirubin >ULN (except those with a documented history of Gilbert's Syndrome). Subjects with AST/ALT/total bilirubin >ULN and <1.5X ULN may be retested once.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
- Females of childbearing potential.
- Subjects with positive responses (score 1) for suicidality on the Sheehan Suicidality Tracking Scale (S-STS) (specifically items 1a, 1b, 3, 4, 5, 6, 7, or 9).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description oral wet milled suspension 300mg PF-04191834 Subjects receive a single dose of PF-04191834 as a suspension oral single dose dispersion 100mg PF-04191834 Subjects receive a single dose of PF-04191834 as a dispersion oral wet milled suspension 100mg PF-04191834 Subjects receive a single dose of PF-04191834 as a suspension
- Primary Outcome Measures
Name Time Method Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834. 3 days Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834. 3 days Time of maximum concentration(Tmax) of PF-04191834 in plasma. 3 days
- Secondary Outcome Measures
Name Time Method Maximum concentration (Cmax) for PF-04191834 in plasma. 3 days Elimination half-life (t1/2) of PF-04191834 3 days Sheehan suicidality tracking scale (SSTS) Screening and last Day of Period 3 Number of adverse events in patients as a measure of safety and tolerability. Throughout the study.