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Bioavailability Study Of PF-06651600 In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02684760
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06651600 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 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 Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
 Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
Experimental: Cohort 2: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
 Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
Experimental: Cohort 3: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
 Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
Experimental: Cohort 4: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
 Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
Experimental: Cohort 5: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
 Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
Experimental: Cohort 6: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
 Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
    Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  3. Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
    Time to Reach Maximum Observed Plasma Concentration (Cmax)


Secondary Outcome Measures :
  1. Plasma Decay Half Life (t1/2) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
    Plasma Decay Half-Life (t1/2)

  2. Time to Reach Maximum Concentration (Tmax) for PF-06651600 [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
    Time to Reach Maximum Concentration (Tmax)


Eligibility Criteria
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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/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Prior history of chicken pox.
  • Evidence of personally signed and dated informed consent document.
  • Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
  • Screening blood pressure >140/90 mm Hg.
  • Screening laboratory abnormalities as defined by the protocol.
  • Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
Contacts and Locations
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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): NCT02684760


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02684760    
Other Study ID Numbers: B7981003
2015-004857-41 ( EudraCT Number )
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Keywords provided by Pfizer:
Inflammatory Bowel Disease