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

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: E6011 Matching Placebo; Drug: E6011

• Registration Number: NCT01731275
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-21
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E6011 Matching Placebo	E6011 Matching Placebo	-
E6011	E6011	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Up to Week 24	An Adverse Event (AE) is any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. The investigator or sub-investigator reviews all laboratory findings and determines if they constitute an AE. In-patient observation assessments will be performed during 1 week post-dose, followed by the out-patient observation assessments in groups: 0.0006, 0.006, 0.04, 0.2 mg/kg up to the end of Week 8 and in groups: 1, 3, 6, 10 kg/mg) up to the end of Week 24.

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	Up to 24 Weeks post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]	Up to 24 Weeks post-dose	AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Plasma Decay Half-Life (t1/2)	Up to 24 Weeks post-dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Pharmacokinetic Parameter: Volume of Distribution (Vd)	Up to 24 Weeks post-dose
Pharmacokinetic Parameter: Clearance (CL)	Up to 24 Weeks post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Up to 24 Weeks post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	Up to 24 Weeks post-dose	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).