NCT01731275

A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)

A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	E6011	A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.
DRUG	E6011 Matching Placebo	A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-11-21
• Last updated: 2014-02-14

Locations

1 site across 1 country: Japan