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Food Effect Study PF-04136309

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NCT02598206

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02598206
Pfizer
Completed
Food Effect Study PF-04136309

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Food Effect Study PF-04136309
A Phase I Randomized Open Label, Single Dose, 2-period Crossover Study To Evaluate Food Effect On The Pharmacokinetics Of Pf-04136309 In Healthy Volunteers.
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
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.
Experimental: Experimental 1

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

A - B B - A

Intervention: Drug: PF-04136309
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02598206
A9421019
2015-003649-24 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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