Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-27 @ 9:35 PM
Study NCT ID:
NCT02533102
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2015-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers
Sponsor:
Eisai Limited
Organization:
Study Overview
Official Title:
Evaluation of E7050 Pharmacokinetics After 100 mg Single Oral Doses Under Fed and Fasted Conditions and Characterization of E7050 Pharmacokinetics After 100 mg, 200 mg and 400 mg Single Oral Doses Under Fasted Condition in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A), and second to characterize E7050 pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B). Part A will be a randomized, single-dose, open-label, three-treatment period crossover study. Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted conditions. Following review of safety data of the 200 mg dose level, an additional 12 subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: