Phase 1
Completed N=18
A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
Healthy
Source: ClinicalTrials.gov NCT01250730 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib — 1423; 3806; 6569 ng*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib |
1423; 3806; 6569 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Crizotinib |
1339; 3732; 6386 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Crizotinib |
70.54; 155.6; 235.8 | — |
| PRIMARY Time to Cmax (Tmax) of Crizotinib |
5.00; 5.00; 5.00 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) of Crizotinib |
41.08; 29.90; 29.13 | — |
| PRIMARY Apparent Oral Clearance (CL/F) of Crizotinib |
105.4; 65.70; 60.87 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Crizotinib |
6170; 2811; 2545 | — |
| PRIMARY Dose Normalized AUC(0-inf) of Crizotinib |
1423; 2284; 2463 | — |
| PRIMARY Dose Normalized AUClast of Crizotinib |
1339; 2239; 2395 | — |
| PRIMARY Dose Normalized Cmax of Crizotinib |
70.54; 93.36; 88.41 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUC0-inf) of Plasma Active Metabolite (PF-06260182) |
180.8; 535.8; 1046 | — |
| 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) |
188.1; 527.2; 1034 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Plasma Active Metabolite (PF-06260182) |
17.24; 37.63; 54.94 | — |
| PRIMARY Time to Cmax (Tmax) of Plasma Active Metabolite (PF-06260182) |
5.00; 5.00; 6.00 | — |
| PRIMARY Metabolite to Parent Ratio AUC(0-inf) |
0.1261; 0.1365; 0.1544 | — |
| PRIMARY Metabolite to Parent Ratio AUClast |
0.1362; 0.1370; 0.1571 | — |
| PRIMARY Metabolite to Parent Ratio Cmax |
0.2371; 0.2346; 0.2260 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01250730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.