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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: crizotinib prototype microsphere 0.420 mg/mg; Drug: crizotinib prototype microsphere 0.529 mg/mg; Drug: crizotinib oral solution; Drug: crizotinib capsule; Drug: Crizotinib prototype microsphere 0.529 mg/mg; Drug: crizotinib prototype microsphere 0.470 mg/mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006277

A8081041

Details and patient eligibility

About

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).

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
• Female subjects of non child bearing potential must have a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Pregnant or nursing females; females of childbearing potential.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Trial design

21 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Cohort 1 will be an open label, randomized, 4 period, 4 treatment, 4 sequence, cross over sensory evaluation of three new prototype formulations (75 mg dose of crizotinib as prototypes 0.529 mg/mg, 0.470 mg/mg and 0.420 mg/mg Microspheres) and OS (75 mg dose of crizotinib)via use of a Crizotinib Taste Assessment - Questionnaire for Cohort 1 in healthy adults.

Treatment:

Drug: Crizotinib prototype microsphere 0.529 mg/mg

Drug: crizotinib prototype microsphere 0.420 mg/mg

Drug: crizotinib oral solution

Drug: crizotinib oral solution

Drug: crizotinib prototype microsphere 0.420 mg/mg

Drug: crizotinib prototype microsphere 0.470 mg/mg

Drug: crizotinib prototype microsphere 0.470 mg/mg

Cohort 2

Experimental group

Description:

This cohort will be an open label, randomized, 5 period, 5 treatment, 4 sequence, cross over single dose bioavailability study employing administration of four crizotinib formulations Treatments E, F, G and H (Crizotinib 250 mg dose Formulated Capsule and 250 mg dose crizotinib as prototypes 0.529 mg/mg, 0.470 mg/mg and 0.420 mg/mg Microspheres, respectively) in the fasted state to healthy adult subjects (Periods 1-4). In addition, Treatment I (250 mg dose of crizotinib OS) will be administered at Period 5, for a taste evaluation only (no pharmacokinetic (PK) sample collection after the dose), in the period immediately following the completion of Period 4 of Cohort 2. A Crizotinib Taste Assessment - Questionnaire for Cohort 2 will be filled by all subjects.

Treatment:

Drug: crizotinib capsule

Drug: crizotinib prototype microsphere 0.420 mg/mg

Drug: crizotinib prototype microsphere 0.529 mg/mg

Drug: crizotinib oral solution

Drug: crizotinib oral solution

Drug: crizotinib prototype microsphere 0.420 mg/mg

Drug: crizotinib prototype microsphere 0.470 mg/mg

Drug: crizotinib prototype microsphere 0.470 mg/mg