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

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731275
• Other study ID #: E6011-J081-001
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2012
• Last updated: February 13, 2014
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

Inclusion criteria;

1. Non-smoking Japanese male subjects aged >= 20 to less than 45 years

2. BMI at screening is >= 18.5 kg/m2 to less than 25.0 kg/m^2

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events	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.	Up to Week 24	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax)		Up to 24 Weeks post-dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Up to 24 Weeks post-dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).	Up to 24 Weeks post-dose	No
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]	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).	Up to 24 Weeks post-dose	No
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Up to 24 Weeks post-dose	No
Secondary	Pharmacokinetic Parameter: Volume of Distribution (Vd)		Up to 24 Weeks post-dose	No
Secondary	Pharmacokinetic Parameter: Clearance (CL)		Up to 24 Weeks post-dose	No