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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01265732
First received: November 30, 2010
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-04191834
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time of maximum concentration(Tmax) of PF-04191834 in plasma. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum concentration (Cmax) for PF-04191834 in plasma. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Elimination half-life (t1/2) of PF-05089771 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Sheehan suicidality tracking scale (SSTS) [ Time Frame: Screening and last Day of Period 3 ] [ Designated as safety issue: Yes ]
  • Number of adverse events in patients as a measure of safety and tolerability. [ Time Frame: Throughout the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: December 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral single dose dispersion 100mg
Subjects receive a single dose of PF-04191834 as a dispersion
Drug: PF-04191834
single dose, 100mg, dispersion
Active Comparator: oral wet milled suspension 100mg
Subjects receive a single dose of PF-04191834 as a suspension
Drug: PF-04191834
single dose, 100mg, suspension
Active Comparator: oral wet milled suspension 300mg
Subjects receive a single dose of PF-04191834 as a suspension
Drug: PF-04191834
single dose, 300mg, suspension

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265732

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01265732     History of Changes
Other Study ID Numbers: B0041012
Study First Received: November 30, 2010
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
relative bioavailability
healthy volunteers
pharmacokinetics
suspension
dispersion

ClinicalTrials.gov processed this record on October 23, 2014