A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01265732

Enrollment

Registered

2010-12-23

Start date

2010-12-31

Completion date

2011-01-31

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase 1, relative bioavailability, healthy volunteers, pharmacokinetics, suspension, dispersion

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.

Interventions

DRUGPF-04191834

single dose, 100mg, dispersion

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. 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).

Design outcomes

Primary

Measure	Time frame
Time of maximum concentration(Tmax) of PF-04191834 in plasma.	3 days
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

Secondary

Measure	Time frame
Maximum concentration (Cmax) for PF-04191834 in plasma.	3 days
Number of adverse events in patients as a measure of safety and tolerability.	Throughout the study.
Elimination half-life (t1/2) of PF-04191834	3 days
Sheehan suicidality tracking scale (SSTS)	Screening and last Day of Period 3

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026