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A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

NCT02006277 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-04-14

No results posted yet for this study

Summary

This study is intended to evaluate the sensory attributes and estimate the relative bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses by "swirl and spit" (Cohort 1) or will receive five oral single 250-mg doses with a washout period of at least 14 days (Cohort 2).

Conditions

  • Healthy

Interventions

DRUG

Crizotinib prototype microsphere 0.529 mg/mg

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

DRUG

crizotinib prototype microsphere 0.470 mg/mg

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

DRUG

crizotinib prototype microsphere 0.420 mg/mg

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

DRUG

crizotinib oral solution

Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.

DRUG

crizotinib prototype microsphere 0.529 mg/mg

Subjects will receive a single 250-mg oral dose of crizotinib.

DRUG

crizotinib prototype microsphere 0.470 mg/mg

Subjects will receive a single 250-mg oral dose of crizotinib.

DRUG

crizotinib prototype microsphere 0.420 mg/mg

Subjects will receive a single 250-mg oral dose of crizotinib.

DRUG

crizotinib capsule

Subjects will receive a single 250-mg oral dose of crizotinib.

DRUG

crizotinib oral solution

Subjects will receive a single 250-mg oral dose of crizotinib.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006277 on ClinicalTrials.gov