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NCT02998775

Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding

Completed EARLY_PHASE1 Last updated 7 September 2018
What this trial tests

EARLY_PHASE1 trial testing Plasma Sampling in Hepatic Impairment; Renal Impairment in 54 participants. Completed in 8 July 2017.

Timeline
2 December 2016
Primary endpoint
8 July 2017
8 July 2017

Quick facts

Lead sponsorEisai Inc.
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposebasic science
Enrollment54
Start date2 December 2016
Primary completion8 July 2017
Estimated completion8 July 2017
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eisai Inc. — full company profile →

Who can join

Adults 18 to 79, any sex, with Hepatic Impairment; Renal Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. The primary objective of the study is to obtain plasma from participants for use in in vitro protein binding studies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Eisai Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02998775.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing