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AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

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: NCT02163161
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04965842 Drug: PF- 04965842 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Treatment A Drug: PF-04965842
Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions

Experimental: Treatment B Drug: PF-04965842
Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions

Experimental: Treatment C Drug: PF- 04965842
Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions




Primary Outcome Measures :
  1. Area Under the Curve from Time Zero to infinity (AUC inf) [ Time Frame: 15 days ]
  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 15 days ]
  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 15 days ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)


Secondary Outcome Measures :
  1. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 15 days ]
  2. Plasma Decay Half-Life (t1/2) [ Time Frame: 15 days ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163161


Locations
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Belgium
Pfizer Investigational Site
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02163161    
Other Study ID Numbers: B7451004
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by Pfizer:
Phase I
Open Label
Single dose
Crossover
Bioavailability
Fasting
Fed
PF-04965842
Healthy