Phase 1
Completed N=15
Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT01149785 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] — 1260.00; 3986.00 ng*hr/mL
Summary
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the single dose pharmacokinetics of crizotinib in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] |
1260.00; 3986.00 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
65.540; 94.470 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
1197.00; 3929.00 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
5.0; 6.0 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
37.1300; 54.8700 | — |
| SECONDARY Apparent Oral Clearance (CL/F) |
122.600; 38.850 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) |
6580.0; 3122.0 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182) |
172.700; 897.400 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Crizotinib Metabolite (PF-06260182) |
178.100; 920.600 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182) |
5.0; 8.0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182) |
16.6900; 26.9400 | — |
| SECONDARY Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast) |
0.1399; 0.2217 | — |
| SECONDARY Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC(0-∞)] |
0.1371; 0.2239 | — |
| SECONDARY Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax) |
0.2469; 0.2766 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female of non-child bearing potential subjects 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 and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- Subjects with evidence of disease, conditions affecting drug absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, and use of prescription , nonprescription drugs and dietary supplement within 7 days, and blood donation of 500 mL within 56 days.
Data sourced from ClinicalTrials.gov (NCT01149785). 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.