Trials / Completed
CompletedNCT04676685
A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose and Single Dose Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and tolerability of E2730 between healthy Japanese and non-Japanese participants following multiple doses. This study will also determine the effect of food on PK of E2730.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E2730 | E2730 capsules. |
| DRUG | E2730-matched placebo | E2730-matched placebo capsules. |
Timeline
- Start date
- 2020-12-16
- Primary completion
- 2021-06-23
- Completion
- 2021-06-23
- First posted
- 2020-12-21
- Last updated
- 2021-08-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04676685. Inclusion in this directory is not an endorsement.