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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Euthymics BioScience, Inc. ( Neurovance, Inc. )
ClinicalTrials.gov Identifier:
NCT01744808
First received: November 19, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Normal, Healthy Volunteers
Drug: EB-1020 IR
Drug: EB-1020 SR1
Drug: EB-1020 SR2
Drug: EB-1020 SR3
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Euthymics BioScience, Inc.:

Primary Outcome Measures:
  • Cmax [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters

  • Tmax [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter

  • AUC [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Pharmacokinetic parameter


Secondary Outcome Measures:
  • Effect of food on Cmax [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744808

Locations
Australia, Victoria
Nucleus Network Ltd.
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Neurovance, Inc.
  More Information

No publications provided

Responsible Party: Euthymics BioScience, Inc. ( Neurovance, Inc. )
ClinicalTrials.gov Identifier: NCT01744808     History of Changes
Other Study ID Numbers: EB-1020-102
Study First Received: November 19, 2012
Last Updated: April 2, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Euthymics BioScience, Inc.:
Healthy
Normal

ClinicalTrials.gov processed this record on August 01, 2014