Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000577213
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
14/07/2009
Date last updated
21/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The pharmacokinetics and clinical tolerability of ascending single doses of BNC210, an anxiolytic compound, in healthy volunteers
Scientific title
The pharmacokinetics and clinical tolerability of ascending single doses of BNC210, an anxiolytic compound, in healthy volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder 237172 0
Condition category
Condition code
Mental Health 237495 237495 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will receive a single oral dose of BNC210. The dose will be administered as a suspension in 10 mL of vehicle. The starting dose will be 5 mg, with 3-fold escalations up to 150 mg, which will be doses of 5, 15 and 50 mg and 150 mg, then 2 fold escalations thereafter with doses of 300, 600 and 1200 mg.
Intervention code [1] 236883 0
Treatment: Drugs
Comparator / control treatment
placebo - the placebo will be 10 mL of the liquid vehicle minus the active ingredient and will be taken as a single oral dose
Control group
Placebo

Outcomes
Primary outcome [1] 238304 0
To determine the pharmacokinetics of single doses of BNC210. Plasma and urine samples will be collected for pharmacokinetic assessment. The samples will be assayed by a validated Liquid Chromatography/Mass Spectrometry (LC/MS) method which is specific for the determination of BNC210
Timepoint [1] 238304 0
from baseline to 32 hours post dose
Primary outcome [2] 238305 0
To determine the clinical tolerability of single doses of BNC210. This will be assessed using scheduled adverse event probes, spontaneous adverse event reporting, physical examination, routine laboratory investigations, Electrocardiogram (ECG) and vital sign evaluations plus clinical chemistry analysis (haematology, biochemistry, urinalysis)
Timepoint [2] 238305 0
from baseline to 8 days (+/- 3 days ) post dosing
Secondary outcome [1] 244696 0
To determine the effects of BNC210 on neurological and psychiatric symptoms using Bond and Lader visual analogue scales.
Timepoint [1] 244696 0
from baseline to 32 hours post dose
Secondary outcome [2] 244697 0
To identify a dose range to be used in subsequent trials.
Timepoint [2] 244697 0
from baseline to 8 days (+/- 3 days ) post dosing

Eligibility
Key inclusion criteria
1. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the principal investigator.
2. Good general mental health as determined by scores on the Symptom Checklist-90-R (SCL-90-R (registered trademark)), a screening instrument which evaluates a broad range of psychological problems and symptoms of psychopathology.
3. Agree to and be capable of signing informed consent form.
4. Have suitable venous access for blood sampling.
5. Body Mass Index within the range of 19-30 kg/m2.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Renal impairment as evidenced by estimated creatinine clearance, measured by the Cockcroft-Gault method of less than 90 mL/min.
2. Have a laboratory value at the Screening Visit that is outside the normal range, unless it is judged by the Investigator as not clinically significant after appropriate evaluation.
3. A score of more than two standard deviations from the mean on any of the key nine scales in the SCL-90-R (registered trademark)
4. Any medical condition that in the opinion of the investigator may adversely impact on the participant’s ability to complete the study.
5. Plasma Aspartate transaminase (AST), Alanine transaminase (ALT), and Alkaline phosphatase (ALP) tests in excess of 1.5 times the upper limit of normal.
6. History of severe allergic or anaphylactic drug-related reactions.
7. Current (within the last six months) clinically significant psychiatric disorder including anxiety or depression.
8. Concurrent use of other medication on a regular or daily basis.
9. Participation in another clinical trial of an investigational agent within 30 days of study entry.
10. Known history of past or present infection with hepatitis C virus (HCV), hepatitis B or human immunodeficiency virus (HIV).
11. Clinically significant abnormal electrocardiogram (ECG) (12-lead) at the screening visit or prior to dosing on Day 1, as determined by the Investigator.
12. Subjects who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at screening or prior to dosing on Day 1 will not be allowed to continue in the study.
13. Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit.
14. Any alcohol use within 24 hours prior to dosing on Day 1.
15. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule.
16. Blood donation (1 unit or more) within 1 month prior to the screening visit.
17. Smoke >5 cigarettes per day.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be entered into the study sequentially and will be randomly allocated to active drug or placebo using a randomisation table created by computer software. In order to maintain the blinding of subject treatment assignments all study site personnel (with the exception of the Pharmacist or designee who is responsible for preparing the study treatment) will be blinded to treatment assignment. All study site personnel performing subject assessments will not be informed of the subject’s treatment assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation -an electronically generated randomisation code created by computer software which will be supplied to the sponsor-contracted pharmacist by the CRO. The pharmacist will number the drug doses so that the allocation of subjects to placebo or active dose will be concealed from the clinical trial site personnel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237274 0
Self funded/Unfunded
Name [1] 237274 0
Bionomics Limited
Country [1] 237274 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
31 Dalgleish Street
Thebarton
Adelaide
South Australia
5082
Country
Australia
Secondary sponsor category [1] 236763 0
None
Name [1] 236763 0
Address [1] 236763 0
Country [1] 236763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239375 0
Research Ethics Committee of the Royal Adelaide Hospital
Ethics committee address [1] 239375 0
Research Ethics Committee
Level 3 Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
5000
Ethics committee country [1] 239375 0
Australia
Date submitted for ethics approval [1] 239375 0
18/03/2009
Approval date [1] 239375 0
08/05/2009
Ethics approval number [1] 239375 0
090421

Summary
Brief summary
This is a phase I trial to assess the safety and tolerability of a new anti-anxiety drug over a wide range of doses. This will enable doses, that are safe and produce good levels of drug in the body, to be selected for further studies in which measurement of anti-anxiety activity may be done.
Trial website
http://www.bionomics.com.au/page.php?section=129
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29857 0
Address 29857 0
Country 29857 0
Phone 29857 0
Fax 29857 0
Email 29857 0
Contact person for public queries
Name 13104 0
Sue O'Connor
Address 13104 0
31 Dalgleish Street
Thebarton
Adelaide
5000
South Australia
Country 13104 0
Australia
Phone 13104 0
+61 8 83546100
Fax 13104 0
Email 13104 0
soconnor@bionomics.com.au
Contact person for scientific queries
Name 4032 0
Sue O'Connor
Address 4032 0
31 Dalgleish Street
Thebarton
Adelaide
5000
South Australia
Country 4032 0
Australia
Phone 4032 0
+61 8 83546100
Fax 4032 0
Email 4032 0
soconnor@bionomics.com.au

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

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