drugset / Trial / NCT05607537

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

NCT05607537

Phase 1 Completed 15 enrolled Eisai Inc.
Non-randomizedParallel-groupOpen-labelBasic science

Summary

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.

Timeline

Start
2022-10-17
Primary completion
2023-08-31
Completion
2023-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject E7386 Small molecule 100 ug Oral
Subject E7386 Small molecule 40 mg Oral

Indications

No indication recorded.