Clinical trial NCT01265732: A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers
Official title: An Open Label, Randomized 3-Way Crossover Single Dose Study To Compare The Pharmacokinetics And Relative Bioavailability Of PF-04191834 Using An Oral Wet-Milled Suspension Formulation Versus An Oral Single Dose Dispersion Formulation Under Fasted Conditions In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
relative bioavailability
healthy volunteers
pharmacokinetics
suspension
dispersion
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Time of maximum concentration(Tmax) of PF-04191834 in plasma.
timeFrame: 3 days
measure: Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834.
timeFrame: 3 days
measure: Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834.
timeFrame: 3 days
Secondary outcomes:
measure: Maximum concentration (Cmax) for PF-04191834 in plasma.
timeFrame: 3 days
measure: Elimination half-life (t1/2) of PF-04191834
timeFrame: 3 days
measure: Sheehan suicidality tracking scale (SSTS)
timeFrame: Screening and last Day of Period 3
measure: Number of adverse events in patients as a measure of safety and tolerability.
timeFrame: Throughout the study.
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: