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

Last updated on December 4, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
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 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.

NCT00918164
Pfizer
Completed
Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects

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Descriptive Information
Brief Title  ICMJE Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects
Official Title  ICMJE 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
Brief SummaryThe 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
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: PF-04457845
Single dose, 8 mg as oral tablet and solution formulation
Study Arms  ICMJE Experimental: Healthy adult volunteers
Standard Phase 1 normal healthy adult volunteers, age range 21-55 years and of either sex
Intervention: Drug: PF-04457845
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: June 9, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion DateJuly 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00918164
Other Study ID Numbers  ICMJE B0541005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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