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PPI And Food Effect Study For PF-06463922 In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02569554
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The current study will be conducted in healthy adult subjects to evaluate the effect of proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the bioavailability of the oral solution relative to the tablet formulation of PF-06463922.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06463922 Drug: rabeprazole Phase 1

Detailed Description:

PF-06463922 is a selective, ATP competitive small molecule tyrosine kinase inhibitor (TKI) of the Anaplastic Lymphoma Kinase (ALK) positive (ALK+) or ROS oncogene 1 (ROS1) positive (ROS1+) receptor tyrosine kinases (RTK) that also potently inhibits ALK kinase domain mutations responsible for resistance to crizotinib. PF-06463922 is being developed as a novel anticancer agent for the treatment of patients with advanced ALK+ NSCLC or ROS1+ NSCLC.

The current study is a Phase 1, randomized, open label, 4 period, 4 treatment, 4 sequence, crossover study conducted in healthy adult subjects. Each subject will receive four single oral doses of 100 mg PF-06463922 as tablets alone, tablets with food, tablets with rabeprazole, and oral solution after overnight fasting with at least a 10 day washout period between each PF-06463922 dose.

Twenty four (24) subjects will be enrolled to obtain at least 20 evaluable subjects who complete all treatments. Subjects who withdraw will not be replaced unless the total number of completed subjects falls below 20.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Crossover, Open-Label, 4 Period Study In Healthy Volunteers To Demonstrate The Lack Of Effect Of Rabeprazole And Food On The Pharmacokinetics Of PF-06463922 And To Assess The Relative Bioavailability Of Oral Solution To The Tablet Formulation Of PF-06463922
Study Start Date : December 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06463922
each subject will receive four single doses of PF-06463922 without food, with food, with rabeprazole (without food), and one of the two new formulations without food.
Drug: PF-06463922
each subject will receive 4 single oral doses of 100 mg PF-06463922 (treatment A: tablets without food; treatment B: tablets with food; treatment C: tablets without food with rabeprazole; treatment D: oral solution without food). There will be at least 10 days washout period between consecutive PF-06463922 single dose.

Drug: rabeprazole
20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C.
Other Name: Pariet




Primary Outcome Measures :
  1. plasma AUCinf for PF-06463922 [ Time Frame: 3 months ]
    area under plasma concentration-time profile from time 0 extrapolated to infinite time for PF-06463922

  2. plasma Cmax for PF-06463922 [ Time Frame: 3 months ]
    observed maximal plasma PF-06463922 concentration


Secondary Outcome Measures :
  1. plasma AUClast for PF-06463922 [ Time Frame: 3 months ]
    area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for PF-06463922

  2. plasma Tmax for PF-06463922 [ Time Frame: 3 months ]
    time to the plasma maximal concentration for PF-06463922

  3. plasma t1/2 for PF-06463922 [ Time Frame: 3 months ]
    plasma terminal half-life for PF-06463922

  4. plasma CL/F for PF-06463922 [ Time Frame: 3 months ]
    apparent clearance for PF-06463922

  5. plasma Vz/F for PF-06463922 [ Time Frame: 3 months ]
    apparent volume of distribution for PF-06463922



Information from the National Library of Medicine

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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 female subjects of non-childbearing potential and/or male subjects
  • 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.
  • Subject must be willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular
  • Any condition possibly affecting drug absorption
  • A positive urine drug screen.
  • Use of tobacco- or nicotine containing products within 90 days of screening or a positive urine cotinine test and history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within 6 months of Screening.

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): NCT02569554


Locations
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Belgium
Pfizer Clinical Research Unit
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: NCT02569554     History of Changes
Other Study ID Numbers: B7461008
2015-003416-21 ( EudraCT Number )
PPI STUDY ( Other Identifier: Alias Study Number )
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Pfizer:
PF-06463922
rabeprazole
proton pump inhibitor (PPI)
pharmacokinetics(PK)
food effect

Additional relevant MeSH terms:
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Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action