CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
crizotinib +2 moredrug
Likely dose
ketoconazole 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01149785
NCT01149785Phase 1Completed
CompareCT.gov

A Phase 1, Fixed Sequence, Cross-Over Study To Estimate The Effect Of Multiple Doses Of Ketoconazole On The Single Dose Pharmacokinetics Of Crizotinib (PF-02341066) In Healthy Volunteers

Pfizer·interventional·Posted Jun 23, 2010·Updated Oct 24, 2011

In Brief

A Phase 1 clinical trial evaluating crizotinib and ketoconazole for Healthy. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2010
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.0 years ago

Interventions

crizotinibdrug

Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.

ketoconazoledrug

Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from Day 1 to Day 16.

crizotinibdrug

Treatment B: A single 150-mg dose of crizotinib will be administered in the fasted state on Day 4 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.