A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066

Healthy Clinical Trial

Official title:

A Phase 1, Open Label, Dose Escalation, Single Oral Dose Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250730
• Other study ID #: A8081022
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2010
• Last updated: October 20, 2011
• Start date: December 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.

Description:

The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects, 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 and clinical laboratory tests).

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

• Subjects who are smoking,

• Subjects with evidence of disease,

• Subjects with conditions affecting absorption,

• Subjects with treatment with other investigational drug within 30 days,

• Subjects with history of regular alcohol consumption,

• Subjects with use of prescription, nonprescription drugs and dietary supplement within 28 days,

• Subjects with blood donation of approximately 400 mL within 3 months or 200 mL within 1 month prior to dosing

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-02341066
Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT.
• PF-02341066
Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs.
• PF-02341066
Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Hachioji-shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib	AUC(0-inf) of crizotinib is estimated from the crizotinib concentration. It is obtained from AUClast plus (Clast/kel).; AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.; Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Crizotinib	AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Maximum Plasma Concentration (Cmax) of Crizotinib		0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Time to Cmax (Tmax) of Crizotinib		0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Terminal Elimination Half-life (t1/2) of Crizotinib	t1/2 of crizotinib is the time measured for the plasma concentration to decrease by one half. It is obtained from a Loge(2)/kel.; Kel = terminal phase elimination rate constant	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Apparent Oral Clearance (CL/F) of Crizotinib	CL/F of crizotinib is obtained from a Dose per AUCinf.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Apparent Volume of Distribution (Vz/F) of Crizotinib	Vz/F of crizotinib is obtained from a Dose / (AUCinf *kel).; Kel = terminal phase elimination rate constant	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Dose Normalized AUC(0-inf) of Crizotinib	Dose normalized (to 150 mg dose) AUC(0-inf) is obtained from AUC(0-inf) / (Dose/150).	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Dose Normalized AUClast of Crizotinib	Dose normalized (to 150 mg dose) AUClast is obtained from AUClast / (Dose/150).	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Dose Normalized Cmax of Crizotinib	Dose normalized (to 150 mg dose) Cmax is obtained from Cmax / (Dose/150).	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUC0-inf) of Plasma Active Metabolite (PF-06260182)	AUC(0-inf) of PF-06260182 is estimated from the PF-06260182 concentration. It is obtained from AUClast plus (Clast/kel).; AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.; Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Plasma Active Metabolite (PF-06260182)	AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Maximum Plasma Concentration (Cmax) of Plasma Active Metabolite (PF-06260182)		0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Time to Cmax (Tmax) of Plasma Active Metabolite (PF-06260182)		0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Metabolite to Parent Ratio AUC(0-inf)	The metabolic ratio (MR) is calculated by first converting the AUC(0-inf) for both crizotinib and metabolite (PF-06260182) from mass units to molar units.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Metabolite to Parent Ratio AUClast	The metabolic ratio (MR) is calculated by first converting the AUClast for both crizotinib and metabolite (PF-06260182) from mass units to molar units.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No
Primary	Metabolite to Parent Ratio Cmax	The metabolic ratio (MR) is calculated by first converting the Cmax for both crizotinib and metabolite (PF-06260182) from mass units to molar units.	0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose	No

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