NCT02533102

Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E7050	100 mg tablet administered orally

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2015-08-26
• Last updated: 2015-11-20

Locations

1 site across 1 country: Netherlands