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Trial record 1 of 1 for:    NCT02598206
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Food Effect Study PF-04136309

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598206
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 4, 2015
First Posted Date  ICMJE November 5, 2015
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Area Under the Curve from time Zero to Extrapolated Infinite Time (AUC[0-inf]). [ Time Frame: 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours (hrs) post-PF-04136309 dose ]
    AUC(0-inf)=Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (o-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
  • Maximum Plasma Concentration [Cmax] [ Time Frame: 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 ]
    Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
  • Time to Reach maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose ]
    Time for Cmax
  • Plasma Decay Half Life (t1/2) [ Time Frame: 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Apparent Oral Clearance (CL/F) [ Time Frame: 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post-PF-04136309 dose ]
    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food Effect Study PF-04136309
Official Title  ICMJE A Phase 1, Randomized, Open Label, Single Dose, 2-period Crossover Study To Evaluate Food Effect On The Pharmacokinetics Of Pf-04136309 In Healthy Subjects
Brief Summary The purpose of this study is to evaluate the effect of food intake on PF-04136309 pharmacokinetics (PK) following a single dose at 1000 mg.
Detailed Description The present study will be conducted in healthy adult subjects. The single dose of 1000 mg has been shown to be safe in a previous study in healthy subjects. To evaluate the effect of food on PF-04136309 PK at the dose of 1000 mg, which is the maximum dose that may be evaluated in the multiple dose setting in patients, will provide information to guide the dose administration in regards to food intake at relevant therapeutic dose levels for further studies in patients.
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-04136309

Treatment A (n=18): a single dose of 1000 mg PF 04136309 will be administered in a fasted state as 8 × 125 mg Tablets.

Treatment B (n=18): a single dose of 1000 mg PF-04136309 will be administered with a high fat breakfast as 8 × 125 mg Tablets.

Study Arms  ICMJE Experimental: Experimental 1

All subjects will receive 2 treatments in one of the indicated sequence orders:

A - B B - A

Intervention: Drug: PF-04136309
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2015)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female subjects of non childbearing potential, who at the time of screening are between the ages of 45 55, and/or male subjects 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 and 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:

  • Subjects who are smoking, or with evidence of disease, conditions affecting absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, use of prescription, nonprescription drugs and dietary supplement within 7 days, or blood donation of 500 mL within 56 days
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02598206
Other Study ID Numbers  ICMJE A9421019
2015-003649-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2018

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