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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01744808




Registration number
NCT01744808
Ethics application status
Date submitted
19/11/2012
Date registered
7/12/2012
Date last updated
3/04/2014

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020
Scientific 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
Secondary ID [1] 0 0
EB-1020-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal, Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EB-1020 IR
Treatment: Drugs - EB-1020 SR1
Treatment: Drugs - EB-1020 SR2
Treatment: Drugs - EB-1020 SR3
Other interventions - Placebo

Active comparator: EB-1020 SR1 - Sustained release formulation

Active comparator: EB-1020 SR2 - Sustained Release Formulation

Active comparator: EB-1020 SR3 - Sustained Release Formulation

Active comparator: EB-1020 IR - Immediate Release Formulation

Placebo comparator: Placebo - Placebo Formulation


Treatment: Drugs: EB-1020 IR
Immediate release

Treatment: Drugs: EB-1020 SR1
sustained release

Treatment: Drugs: EB-1020 SR2
Sustained release

Treatment: Drugs: EB-1020 SR3
Sustained release

Other interventions: Placebo
Placebo formulation
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
up to 6 months
Primary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
up to 6 months
Primary outcome [3] 0 0
AUC
Timepoint [3] 0 0
up to 6 months
Secondary outcome [1] 0 0
Effect of food on Cmax
Timepoint [1] 0 0
up to 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Neurovance, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01744808