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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569554
• Other study ID #: B7461008
• Secondary ID: 2015-003416-21PP
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2015
• Last updated: May 11, 2016
• Start date: December 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma AUCinf for PF-06463922	area under plasma concentration-time profile from time 0 extrapolated to infinite time for PF-06463922	3 months	No
Primary	plasma Cmax for PF-06463922	observed maximal plasma PF-06463922 concentration	3 months	No
Secondary	plasma AUClast for PF-06463922	area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for PF-06463922	3 months	No
Secondary	plasma Tmax for PF-06463922	time to the plasma maximal concentration for PF-06463922	3 months	No
Secondary	plasma t1/2 for PF-06463922	plasma terminal half-life for PF-06463922	3 months	No
Secondary	plasma CL/F for PF-06463922	apparent clearance for PF-06463922	3 months	No
Secondary	plasma Vz/F for PF-06463922	apparent volume of distribution for PF-06463922	3 months	No

External Links

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