A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
P-glycoproteinHealthy Volunteers
Interventions
DRUG

Lenvatinib

subjects will take a single oral dose of 24 mg lenvatinib on three separate occasions (Period 1, Day 1; Period 2, Day 15; and Period 3, Day 43). In Period 2, Day 15, subjects will also take a single oral dose of 600 mg po rifampin. In Period 3, subjects will receive 600 mg rifampin po daily for 21 days (Period 3, Days 29 to 49). On Day 43 of Period 3, subjects will take 24 mg lenvatinib in addition to the rifampin.

Trial Locations (1)

98418

Tacoma

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT02199392 - A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers | Biotech Hunter | Biotech Hunter