Clinical trials: Lenvatinib
Hepatic Impairment, Hepatic Function
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal…
- Trial name
- NCT02421042
- Testing
- Lenvatinib
- Where
- 5 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
P-glycoprotein, Healthy Volunteers
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
The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvatinib…
- Trial name
- NCT02199392
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Pharmacokinetic Study to Assess the Influence of Simultaneous CYP3A4 and P-glycoprotein Inhibition on E7080 Pharmacokinetics Following Single Dose Oral Administration of 5 mg E7080 to Healthy Volunteers
The purpose of this study is to assess the influence of simultaneous CYP3A4 and p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg lenvatinib.
- Trial name
- NCT02198170
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Cancer
E7080 Food Effect Study in Healthy Subjects
This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization.
- Trial name
- NCT01240408
- Testing
- HOPE
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Refractory Solid Tumors, Lymphomas
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization.
- Trial name
- NCT01525394
- Testing
- Lenvatinib, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers
The study will be conducted in adult healthy participants and will consist of two phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a Screening Period and a Baseline Period.
- Trial name
- NCT02792829
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are…
- Trial name
- NCT02723630
- Testing
- Lenvatinib 10 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Renal Impairment, Disease Severity
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with…
- Trial name
- NCT02199379
- Testing
- Lenvatinib
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Hepatic Impairment; Renal Impairment
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants.
- Trial name
- NCT02998775
- Testing
- Plasma Sampling
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.