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

NCT01265732

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04191834
    single dose, 100mg, dispersion
  • Drug: PF-04191834
    single dose, 100mg, suspension
  • Drug: PF-04191834
    single dose, 300mg, suspension
Study Arms  ICMJE
  • Active Comparator: oral single dose dispersion 100mg
    Subjects receive a single dose of PF-04191834 as a dispersion
    Intervention: Drug: PF-04191834
  • Active Comparator: oral wet milled suspension 100mg
    Subjects receive a single dose of PF-04191834 as a suspension
    Intervention: Drug: PF-04191834
  • Active Comparator: oral wet milled suspension 300mg
    Subjects receive a single dose of PF-04191834 as a suspension
    Intervention: Drug: PF-04191834
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 15, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2010)
12
Estimated Study Completion Date  ICMJE January 2011
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01265732
Other Study ID Numbers  ICMJE B0041012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP