Trials / Completed
CompletedNCT05607537
A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-14 (14C)E7386 in Healthy Male Participants
An Open-Label, Single-Center, 2-Part, Parallel Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of [14C]E7386 in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Eisai Limited · Industry
- Sex
- Male
- Age
- 30 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E7386 Tablet | E7386 40 mg tablet. |
| DRUG | (14C)E7386 Capsule | (14C)E7386 40 mg capsule. |
| DRUG | (14C)E7386 | (14C)E7386 administered intravenously. |
Timeline
- Start date
- 2022-10-17
- Primary completion
- 2023-08-31
- Completion
- 2023-08-31
- First posted
- 2022-11-07
- Last updated
- 2023-09-21
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05607537. Inclusion in this directory is not an endorsement.