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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01265732
• Other study ID #: B0041012
• Status: Withdrawn
• Phase: Phase 1
• First received: November 30, 2010
• Last updated: October 15, 2015
• Start date: December 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-04191834
single dose, 100mg, dispersion
• PF-04191834
single dose, 100mg, suspension
• PF-04191834
single dose, 300mg, suspension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of maximum concentration(Tmax) of PF-04191834 in plasma.		3 days	No
Primary	Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834.		3 days	No
Primary	Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834.		3 days	No
Secondary	Maximum concentration (Cmax) for PF-04191834 in plasma.		3 days	No
Secondary	Elimination half-life (t1/2) of PF-04191834		3 days	No
Secondary	Sheehan suicidality tracking scale (SSTS)		Screening and last Day of Period 3	Yes
Secondary	Number of adverse events in patients as a measure of safety and tolerability.		Throughout the study.	Yes

External Links

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