Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00918164
First received: May 5, 2009
Last updated: July 9, 2009
Last verified: July 2009
  Purpose

The purpose of this study is to estimate the bioavailability of PF-04457845 tablets relative to solution and evaluate the effect of food (fasted vs. high fat meal) on the pharmacokinetics of an oral tablet formulation of PF-04457845


Condition Intervention Phase
Healthy Volunteers
Drug: PF-04457845
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized, Open-Label, Single Dose, Crossover Study To Evaluate The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And To Assess Food Effect In Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma pharmacokinetics [ Time Frame: up to 96 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and toleration including adverse events, vital signs measurements, 12-lead ECGs, Physical examination findings, Blood and urine safety tests. [ Time Frame: pre-dose to follow up ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy adult volunteers
Standard Phase 1 normal healthy adult volunteers, age range 21-55 years and of either sex
Drug: PF-04457845
Single dose, 8 mg as oral tablet and solution formulation

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects or healthy female subjects of non-child bearing potential. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete 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);
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial;
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
  • Willing and able to consume a non-vegetarian high-fat meal.

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 time of dosing);
  • History of febrile illness within 5 days prior to the first dose;
  • Any condition possibly affecting drug absorption (eg, gastrectomy);
  • A positive urine drug screen;
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening;
  • Treatment with an investigational drug within 30 days or 5 half-lives (or determined by the local requirement, whichever is longer) preceding the first dose of trial medication;
  • 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility;
  • Pregnant or nursing females and females of child-bearing potential;
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication;
  • Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of trial medication. Other exceptions may be granted by a qualified member of Pfizer study management;
  • Unwillingness to refrain from consumption of grapefruit/pomelo or grapefruit/pomelocontaining products from 7 days prior to the first dose of study medication until the completion of the follow-up visit.
  • Blood donation of approximately 1 unit (~500 mL) within 56 days prior to dosing;
  • Unwillingness or inability to comply with the Lifestyle guidelines;
  • Subject is the Investigator or sub-Investigator, research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study;
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00918164

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
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: NCT00918164     History of Changes
Other Study ID Numbers: B0541005
Study First Received: May 5, 2009
Last Updated: July 9, 2009
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014