Status:
COMPLETED
Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Healthy Volunteers
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief Summary
This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subjects must meet all of the following criteria to be included in this study:
- Healthy Japanese male subjects aged 20 to 44 years at the time of informed consent.
- Has voluntarily consented, in writing, to participate in this study.
- Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.
- Exclusion criteria
- Subjects who meet any of the following criteria will be excluded from this study:
- Has a clinically significant medical condition requiring treatment within 8 weeks before the initial study drug administration, or a history of clinically significant infection requiring treatment within 4 weeks before the initial drug administration.
- History of surgical treatment such as resection of the liver, kidney, or Gastrointestinal tract, that may affect the Pharmacokinetic profiles of study drugs.
- Ineligible for study participation in the opinion of the investigator or sub-investigator.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02268838
Start Date
October 1 2014
End Date
November 1 2015
Last Update
January 20 2016
Active Locations (1)
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1
Sumida-ku, Tokyo, Japan