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A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets Compared to an E7386 Immediate Release (IR) Tablet in Healthy Adult Participants

NCT04840927 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-11-24

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the pharmacokinetic (PK) profile of E7386 following oral administration of E7386 enteric coated TR prototype tablet formulations (TR1, TR2 and optional TR3) and to evaluate the relative bioavailability of E7386 TR tablets compared to E7386 IR reference tablet.

Conditions

  • Healthy Volunteers

Interventions

DRUG

E7386

Regimen A: 40 milligram (mg) IR Oral Tablet.

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2023-05-17
Completion
2023-05-17

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840927 on ClinicalTrials.gov