Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

April 18, 2016

Primary Completion Date

January 4, 2017

Study Completion Date

August 16, 2018

Conditions
Tumors
Interventions
DRUG

Lenvatinib

Lenvatinib 24 mg (as one 4 mg and two 10 mg capsules) will be administered orally once daily with 240 mL (8 fluid oz) of water each morning, starting on Cycle 1 Day 1, in 28-day cycles.

DRUG

Midazolam

Midazolam syrup 4 mg will be administered orally after an overnight fast on Cycle 1 Day -3 and concurrently with lenvatinib on Day 1 and Day 14 of Cycle 1. Participants will have to remain fasting for 2 hours after each dose of midazolam.

Trial Locations (4)

Unknown

Facility # 1, Detroit

Facility # 1, The Bronx

Facility # 1, Philadelphia

Facility # 1, San Antonio

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT02686164 - Phase 1 Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam in Subjects With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter