An Open-Label, Single Dose Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants

Eisai Clinical Trials

Protocol # E2086-A001-004

Study Overview

Study Compound: E2086

Drug Name:

Registry #: NCT07308236

Trial Period: -

Indication: Healthy Volunteers

Primary Endpoint: 1. Mass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled Dose [Time Frame: Day 1 up to Day 21]

2. Maximum Observed Concentration (Cmax) of [14C]E2086 for Total Radioactivity (TRA) in Plasma [Time Frame: Day 1 up to Day 21]

3. Time to Reach Cmax (Tmax) of [14C]E2086 for TRA in Plasma [Time Frame: Day 1 up to Day 21]

4. Area Under the Concentration-time Curve from Zero Time to Time of Last Quantifiable Concentration [AUC (0-t)] of [14C]E2086 for TRA in Plasma [Time Frame: Day 1 up to Day 21]

Population
Males and females 18 Years to 55 Years (Adult)
Study Status
Not started
Study Phase
Phase 1
Countries
United States

Clinical Trial Documents

Clinical Study Report Synopsis

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Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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Publication reference citation

Data Sharing

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CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR