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A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01744808
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
Euthymics BioScience, Inc. ( Neurovance, Inc. )

Brief Summary:
To investigate whether there is a food-effect with oral administration with EB-1020 as well as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.

Condition or disease Intervention/treatment Phase
Normal, Healthy Volunteers Drug: EB-1020 IR Drug: EB-1020 SR1 Drug: EB-1020 SR2 Drug: EB-1020 SR3 Other: Placebo Phase 1

Detailed Description:
  • To investigate the safety and tolerance of single doses of EB-1020 immediate release (IR) versus three sustained release (SR) formulations.
  • To investigate the safety and tolerance of a single oral dose of a SR formulation of EB-1020 in the fed and fasted state.
  • To investigate the safety, tolerance, and cognitive effects of multiple oral rising doses of a SR formulation of EB-1020.

Secondary Objectives

  • To characterize the single dose and steady state pharmacokinetic profiles of EB-1020 SR formulations.
  • To investigate the effect of food on the pharmacokinetic profile of EB-1020 SR following single oral doses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1 Study To Investigate the Pharmacokinetics of SR Formulations; and the Food Effect, Safety, Tolerance, Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020 In Young Healthy Subjects
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Active Comparator: EB-1020 SR1
Sustained release formulation
Drug: EB-1020 SR1
sustained release

Active Comparator: EB-1020 SR2
Sustained Release Formulation
Drug: EB-1020 SR2
Sustained release

Active Comparator: EB-1020 SR3
Sustained Release Formulation
Drug: EB-1020 SR3
Sustained release

Active Comparator: EB-1020 IR
Immediate Release Formulation
Drug: EB-1020 IR
Immediate release

Placebo Comparator: Placebo
Placebo Formulation
Other: Placebo
Placebo formulation

Primary Outcome Measures :
  1. Cmax [ Time Frame: up to 6 months ]
    Pharmacokinetic parameters

  2. Tmax [ Time Frame: up to 6 months ]
    Pharmacokinetic parameter

  3. AUC [ Time Frame: up to 6 months ]
    Pharmacokinetic parameter

Secondary Outcome Measures :
  1. Effect of food on Cmax [ Time Frame: up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Aged 18-45 years inclusive
  2. Body weight with the normal range for height (body mass index [BMI] between 19-30 kg/m2 inclusive)
  3. If female, be of non-child bearing potential (surgically sterile, post-menopausal for 12 months or receiving a stable dose of implanted or injectable contraceptive for at least 3 months with last dose of injectable contraceptive within 2 months). Non-surgical menopause history must be confirmed by follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels as defined by established lab ranges.
  4. Be in general good health without clinically significant medical history
  5. Have clinical laboratory test results that are within the laboratory reference range; or if out of range are not clinically relevant and are acceptable to the Investigator and Sponsor medical representative
  6. Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis Screening test
  7. Able and willing to give written informed consent

Exclusion Criteria:

  1. Receipt of any investigational agent or drug within 3 months of entry into the study
  2. Use of prescription drugs within 4 weeks prior to first dosing. Subjects who have used over the counter medication excluding paracetamol, topical over the counter medications and routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as non-clinically relevant by the Principal Investigator and Sponsor
  3. A history of, or current evidence for, suicidal ideation, based upon clinical interview and a psychiatric questionnaire
  4. A history of known or suspected seizures, spasms, infantile spasms, febrile convulsions, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits)
  5. A history of sleep problems in the last 3 months
  6. A history of relevant atopy or drug hypersensitivity
  7. A history (within the last 5 years) or evidence of alcohol or drug abuse. Subject who consume more than 14 units (female) or 21 (male) units of alcohol a week (unit = 1 glass (125 mL) of wine = 1 measure of spirits = ½ pint of beer) will also be ineligible
  8. A positive urine test for drugs of abuse or alcohol at Screening or on the day of admittance to the Study Unit
  9. A history of smoking in the last 3 months
  10. Have a significant infection (such as influenza) or known inflammatory process on screening or admission
  11. Have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhea, heartburn )
  12. Have previously received EB-1020
  13. Be vegetarians, vegans or have medical dietary restrictions
  14. Any major surgical procedure within one month of entry into the study
  15. Have difficulties communicating reliably with the Investigator or appear unlikely to co-operate with the requirements of the study in the investigator's judgment.
  16. Any other condition which in the view of the Investigator is likely to interfere with study or put the subject at risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01744808

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Australia, Victoria
Nucleus Network Ltd.
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Neurovance, Inc.
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Responsible Party: Neurovance, Inc. Identifier: NCT01744808    
Other Study ID Numbers: EB-1020-102
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014
Keywords provided by Euthymics BioScience, Inc. ( Neurovance, Inc. ):