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Completed

NCT Number: NCT01731275

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

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

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Key information

Conditions

Healthy Male Volunteers

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sagamihara, Kanagawa, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

;

  • Non-smoking Japanese male subjects aged >= 20 to less than 45 years
  • BMI at screening is >= 18.5 kg/m2 to less than 25.0 kg/m^2
  • 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

;

  • Has been treated with biologic products (except for immunoglobulin preparation)
  • Have received immunoglobulin or blood preparation within 6 months before the study drug administration
  • Received inoculation within 4 weeks before the study drug administration
  • Has a history of autoimmune disease or immunodeficiency
  • Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
  • Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterate
  • With gross hematuria, occult bleeding in urine (>=1+) and urine protein (>=1+) , or either of (>=2+) at screening
  • Has a clinically significant vasculitis (e.g., multiple mononeuropathy)
  • 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
  • Known to be positive for human T-cell lymphotropic virus type 1 (HTVL-1) antibody at screening
  • Known to be positive for QuantiFERON-TB Gold Test
  • Treated with ethical drug(s) within 4 weeks before the study drug administration (except for disinfectants, eye drops)
  • Treated with non-prescription drug(s) within 2 weeks before the study drug administration (except for disinfectants, eye drops)
  • Has participated in another clinical trial and received an investigational drug or device within 6 months before the study drug administration
  • 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.

Treatment and study plan

E6011

Drug

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.

E6011 Matching Placebo

Drug

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.

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: 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 outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 24 Weeks post-dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to 24 Weeks post-dose

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

    Time frame: 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).

  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]

    Time frame: 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).

  5. Plasma Decay Half-Life (t1/2)

    Time frame: Up to 24 Weeks post-dose

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  6. Pharmacokinetic Parameter: Volume of Distribution (Vd)

    Time frame: Up to 24 Weeks post-dose

  7. Pharmacokinetic Parameter: Clearance (CL)

    Time frame: Up to 24 Weeks post-dose

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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