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AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

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NCT02163161

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
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 male subjects and female subjects of non childbearing potential between the
ages of 18 and 55 years, inclusive.

- 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 received within 7 days prior to the first dose of study medication or are
likely to receive during the study any moderate strong inhibitors of CYP3A4, eg,
itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or
diltiazem.

- Subjects who received within 28 days or are likely to receive during the study
inducers of CYP3A4, eg rifampin.

NCT02163161
Pfizer
Completed
AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

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Pfizer Clinical Trials Contact Center

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[email protected]

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AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects
A Phase 1, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects
Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-04965842
    Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions
  • Drug: PF-04965842
    Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions
  • Drug: PF- 04965842
    Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions
  • Experimental: Treatment A
    Intervention: Drug: PF-04965842
  • Experimental: Treatment B
    Intervention: Drug: PF-04965842
  • Experimental: Treatment C
    Intervention: Drug: PF- 04965842
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects and female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
  • 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 received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
  • Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02163161
B7451004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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