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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01731275
First received: August 31, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Male Volunteers
 Drug: E6011
Drug: E6011 Matching Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
    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:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 24 Weeks post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to 24 Weeks post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Up to 24 Weeks post-dose ] [ Designated as safety issue: No ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: Up to 24 Weeks post-dose ] [ Designated as safety issue: No ]
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

  • Plasma Decay Half-Life (t1/2) [ Time Frame: Up to 24 Weeks post-dose ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Pharmacokinetic Parameter: Volume of Distribution (Vd) [ Time Frame: Up to 24 Weeks post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetic Parameter: Clearance (CL) [ Time Frame: Up to 24 Weeks post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E6011 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.
Placebo Comparator: E6011 Matching Placebo 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.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria;

  1. Non-smoking Japanese male subjects aged ≥ 20 to < 45 years
  2. BMI at screening is ≥ 18.5 kg/m2 to < 25.0 kg/m2
  3. Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period.

Exclusion criteria;

  1. Has been treated with biologic products (except for immunoglobulin preparation)
  2. Have received immunoglobulin or blood preparation within 6 months before the study drug administration
  3. Received inoculation within 4 weeks before the study drug administration
  4. Has a history of autoimmune disease or immunodeficiency
  5. Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
  6. Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterate
  7. With gross hematuria, occult bleeding in urine (≥1+) and urine protein (≥1+) , or either of (≥2+) at screening
  8. Has a clinically significant vasculitis (e.g., multiple mononeuropathy)
  9. Known to be positive for human immunodeficiency virus (HIV antigen and antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibody, or syphilis serology test
  10. Known to be positive for human T-cell lymphotropic virus type 1 (HTVL-1) antibody at screening
  11. Known to be positive for QuantiFERON-TB Gold Test
  12. Treated with ethical drug(s) within 4 weeks before the study drug administration (except for disinfectants, eye drops)
  13. Treated with non-prescription drug(s) within 2 weeks before the study drug administration (except for disinfectants, eye drops)
  14. Has participated in another clinical trial and received an investigational drug or device within 6 months before the study drug administration
  15. Received blood transfusion within 1 year, 400 mL or more whole blood donation within 12 weeks, or 200 mL or more whole blood donation within 4 weeks, or blood constituent donation within 2 weeks before the study drug administration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731275

Locations
Japan
Sagamihara, Kanagawa, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Kiyoshi Oketani KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01731275     History of Changes
Other Study ID Numbers: E6011-J081-001
Study First Received: August 31, 2012
Last Updated: April 25, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Healthy volunteers
immunogenicity
anti-E6011 antibody

ClinicalTrials.gov processed this record on May 16, 2013