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

NCT ID: NCT02569554

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-04-30

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.

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.

Conditions

Healthy

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PF-06463922

Intervention Type: DRUG

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.

rabeprazole

Intervention Type: DRUG

20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C.

Interventions

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.

Intervention Type: DRUG

rabeprazole

20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C.

Intervention Type: DRUG

Other Intervention Names

Pariet

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Clinical Research Unit

Brussels, , Belgium

Countries

Belgium

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7461008&StudyName=A%20Phase%201%2C%20Randomized%2C%20Crossover%2C%20Open-label%2C%204%20Period%20Study%20In%20Healthy%20Volunteers%20To%20Demonstrate%20The%20Lack%20Of%20Effect%20Of%20Rabeprazole%20And%20Food%20On%20The%20Pharmacokinetics%20Of%20Pf-06463922%20And%20To%20Assess%20The%20Relative%20Bioavailability%20Of%20Oral%20Solution%20To%20The%20Tablet%20Formulation%20Of%20Pf-06463922

To obtain contact information for a study center near you, click here.

Other Identifiers

2015-003416-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PPI STUDY

Identifier Type: OTHER

Identifier Source: secondary_id

B7461008

Identifier Type: -

Identifier Source: org_study_id