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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.
 
ClinicalTrials.gov Identifier: NCT01744808
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Euthymics BioScience, Inc. ( Neurovance, Inc. )

Tracking Information
First Submitted Date  ICMJE November 19, 2012
First Posted Date  ICMJE December 7, 2012
Last Update Posted Date April 3, 2014
Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2012)
  • Cmax [ Time Frame: up to 6 months ]
    Pharmacokinetic parameters
  • Tmax [ Time Frame: up to 6 months ]
    Pharmacokinetic parameter
  • AUC [ Time Frame: up to 6 months ]
    Pharmacokinetic parameter
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Cmax, Tmax, half-life [ Time Frame: up to 6 months ]
Pharmacokinetic parameters
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2012)
Effect of food on Cmax [ Time Frame: up to 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Normal, Healthy Volunteers
Intervention  ICMJE
  • Drug: EB-1020 IR
    Immediate release
  • Drug: EB-1020 SR1
    sustained release
  • Drug: EB-1020 SR2
    Sustained release
  • Drug: EB-1020 SR3
    Sustained release
  • Other: Placebo
    Placebo formulation
Study Arms  ICMJE
  • Active Comparator: EB-1020 SR1
    Sustained release formulation
    Intervention: Drug: EB-1020 SR1
  • Active Comparator: EB-1020 SR2
    Sustained Release Formulation
    Intervention: Drug: EB-1020 SR2
  • Active Comparator: EB-1020 SR3
    Sustained Release Formulation
    Intervention: Drug: EB-1020 SR3
  • Active Comparator: EB-1020 IR
    Immediate Release Formulation
    Intervention: Drug: EB-1020 IR
  • Placebo Comparator: Placebo
    Placebo Formulation
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2014)
54
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2012)
58
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744808
Other Study ID Numbers  ICMJE EB-1020-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Euthymics BioScience, Inc. ( Neurovance, Inc. )
Study Sponsor  ICMJE Neurovance, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Euthymics BioScience, Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP