Clinical trial NCT02569554: PPI And Food Effect Study For PF-06463922 In Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-06463922
rabeprazole
proton pump inhibitor (PPI)
pharmacokinetics(PK)
food effect
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-10-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: plasma AUCinf for PF-06463922
timeFrame: 3 months
measure: plasma Cmax for PF-06463922
timeFrame: 3 months
Secondary outcomes:
measure: plasma AUClast for PF-06463922
timeFrame: 3 months
measure: plasma Tmax for PF-06463922
timeFrame: 3 months
measure: plasma t1/2 for PF-06463922
timeFrame: 3 months
measure: plasma CL/F for PF-06463922
timeFrame: 3 months
measure: plasma Vz/F for PF-06463922
timeFrame: 3 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: