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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

Australia, Victoria

Nucleus Network Ltd.

Melbourne, Victoria, Australia, 3004

Sponsors and Collaborators

Neurovance, Inc.

More Information

• Responsible Party: Neurovance, Inc.
• ClinicalTrials.gov Identifier: NCT01744808
• Other Study ID Numbers: EB-1020-102
• First Posted: December 7, 2012
• Last Update Posted: April 3, 2014
• Last Verified: April 2014

Keywords provided by Euthymics BioScience, Inc. ( Neurovance, Inc. ):

Healthy; Normal