Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01297595

First received: February 15, 2011

Last updated: February 15, 2012

Last verified: February 2012

History of Changes

Results First Received: January 5, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Healthy
Intervention:	Drug: crizotinib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF	Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC	Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.

Participant Flow for 3 periods

Period 1: First Intervention Period

	Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF	Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Period 2: Washout Period (At Least 14 Days)

	Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF	Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Period 3: Second Intervention Period

	Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF	Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	22
Age [units: years] Mean ± Standard Deviation	38.0 ± 11.9
Gender [units: participants]
Female	0
Male	22

Outcome Measures

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1. Primary:

Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dose ]

Show Outcome Measure 1

2. Secondary:

Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 2

3. Secondary:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 3

4. Secondary:

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 4

5. Secondary:

Plasma Terminal Half-Life (t1/2) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 5

6. Secondary:

Apparent Oral Clearance (CL/F) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 6

7. Secondary:

Apparent Volume of Distribution (Vz/F) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 7

8. Secondary:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 8

9. Secondary:

Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 9

10. Secondary:

Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 10

11. Secondary:

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 11

12. Secondary:

Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 12

13. Secondary:

Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 13

14. Secondary:

Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Infinite Time [MRAUC (0- ∞)] [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

Show Outcome Measure 14

Serious Adverse Events

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Other Adverse Events

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