NCT05607537 is a Phase 1 clinical trial of E7386 Tablet in Healthy Volunteers, sponsored by Eisai Limited.

Who is sponsoring NCT05607537?

NCT05607537 is sponsored by Eisai Limited.

What drugs are being tested in NCT05607537?

Interventions in NCT05607537: E7386 Tablet, (14C)E7386 Capsule, (14C)E7386.

What condition does NCT05607537 study?

NCT05607537 studies Healthy Volunteers.

Is NCT05607537 still recruiting?

NCT05607537 is currently completed. Last updated 21 September 2023.

Last reviewed 2023-09-21 · How we verify

NCT05607537

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-14 (14C)E7386 in Healthy Male Participants

Completed Phase 1 Last updated 21 September 2023

What this trial tests

Phase 1 trial testing E7386 Tablet in Healthy Volunteers in 15 participants. Completed in 31 August 2023.

Timeline

17 October 2022

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	Eisai Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	15
Start date	17 October 2022
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

E7386 Tablet
(14C)E7386 Capsule — full drug profile →
(14C)E7386

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Eisai Limited — full company profile →

Who can join

Adults 30 to 55, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to evaluate the absolute bioavailability of E7386 following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR) tablet and concomitant intravenous (IV) microdose of (14C)E7386 (100 mcg \[microgram\]) solution for Part 1 and to determine the pharmacokinetic (PK) and excretion of E7386 following a single 40 mg powder in capsule (PIC) oral administration of (14C)E7386 for Part 2.

Publications & conference data

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

Verify or expand the search:

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Other Eisai Limited trials

Trials by the same sponsor.

NCT06043700 — A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology · active not recruiting
NCT04840927 — A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets · Phase 1 · withdrawn
NCT04493255 — A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants · Phase 1 · completed
NCT04252846 — A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants · completed
NCT04257604 — A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05607537 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Limited
Last refreshed: 21 September 2023

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/NCT05607537.

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