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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: October 5, 2015
Last updated: NA
Last verified: October 2015
History: No changes posted

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 explore the relative bioavailability of PF-06463922 oral solution and new tablet formulation to the tablet formulation used in clinical studies.

Condition Intervention Phase
Drug: PF-06463922
Drug: rabeprazole
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Crossover, Open-Label, 4 Period Study In Healthy Volunteers To Estimate The Effect Of Rabeprazole And Food On The Pharmacokinetics Of PF-06463922 With Additional Preliminary Evaluations Of PF-06463922 Oral Solution Formulation And New Free Base Tablet Formulation

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • plasma AUCinf for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    area under plasma concentration-time profile from time 0 extrapolated to infinite time for PF-06463922

  • plasma Cmax for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    observed maximal plasma PF-06463922 concentration

Secondary Outcome Measures:
  • plasma AUClast for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for PF-06463922

  • plasma Tmax for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    time to the plasma maximal concentration for PF-06463922

  • plasma t1/2 for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    plasma terminal half-life for PF-06463922

  • plasma CL/F for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    apparent clearance for PF-06463922

  • plasma Vz/F for PF-06463922 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    apparent volume of distribution for PF-06463922

Estimated Enrollment: 24
Study Start Date: November 2015
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06463922
each subject will receive four single doses of PF-06463922 without food, with food, with Pariet (without food), and one of the two new formulations without food.
Drug: PF-06463922
each subject will receive 3 single oral doses of 100 mg PF-06463922 (treatment A: Free Base Tablets containing dry-milled API without food; treatment B: Free Base Tablets containing dry-milled API with food; Treatment C: Free Base Tablets containing dry-milled API without food with rabeprazole). each subject will also receive a single dose of 100 mg PF-06463922 oral solution or PF-066463922 Free Base Tablets containing HSWM API 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

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 will be conducted in healthy adult subjects who will receive four single doses of 100 mg PF-06463922 alone, with food, or with rabeprazole, after overnight fasting with at least a 10 day washout period between each PF-06463922 dose. This will be a Phase 1, randomized, open label, 4 period, 5 treatment, 6 sequence, crossover study employing administration of single oral doses of PF-06463922 without food, with food, or with rabeprazole (without food), and two alternative formulations of PF-06463922 (without food).

Twenty four (24) subjects will be enrolled to obtain at least 18 evaluable subjects who complete treatments A, B and C. Each subject will receive three treatments (A, B and C) with a washout period of at least 10 days between each PF-06463922 dose in first 3 study periods. In study Period 4, 12 subjects (half of the total 24) will receive treatment D and the other 12 subjects will receive treatment E. Subjects who withdraw will not be replaced unless the number of completed subjects falls below 3 per sequence in treatments A, B or C.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02569554

Contact: Pfizer Call Center 1-800-718-1021

Brussel CRU Not yet recruiting
Brussels, Belgium, 1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided

Responsible Party: Pfizer Identifier: NCT02569554     History of Changes
Other Study ID Numbers: B7461008, 2015-003416-21, PPI STUDY
Study First Received: October 5, 2015
Last Updated: October 5, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses processed this record on October 06, 2015