Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000442000
Ethics application status
Approved
Date submitted
5/05/2010
Date registered
1/06/2010
Date last updated
13/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of food on the pharmacokinetcs, tolerability and pharmacodynamics of BNC210 in healthy male volunteers
Scientific title
The effect of food on the pharmacokinetcs, tolerability and pharmacodynamics of BNC210 in healthy male volunteers
Secondary ID [1] 251892 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder 257289 0
Condition category
Condition code
Mental Health 257626 257626 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive up to four dose of BNC210 - 300, 600, 1200,and 2000 mg. Doses of 300, 600 and 1200mg of BNC210 will be administered as an oral suspension in 10 mL of vehicle or 10 mL vehicle alone (placebo). Participants in the 2000 mg of BNC210 dosing group (Period 5) will be given an oral suspension in 20 mL of vehicle or 20 mL of vehicle alone (placebo).

The starting dose in this study is 300 mg of BNC210 or placebo without food. The following week, the same 4 participants will receive 300 mg of BNC210 or placebo with food. If there is a >50% increase in drug exposure with food, then the participants' will be dose escalated - with a one week washout period between each dose. Escalation to the next dose will be decided in a safety review meeting held before the next dosing period.
Intervention code [1] 256424 0
Treatment: Drugs
Comparator / control treatment
Placebo - 10-20 mL liquid vehicle
Control group
Placebo

Outcomes
Primary outcome [1] 258359 0
To determine the effect of food on the pharmacokinetics of BNC210 by measuring levels of BNC210 in plasma samples collected during the study.
Timepoint [1] 258359 0
Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24 hours post-dose
Primary outcome [2] 258360 0
To determine the general clinical tolerability of BNC210 by assessing vital signs, electrocardiogram (ECG) readings, and performing routine haematology and clinical chemistry assessments on blood and urine samples collected during the study.
Timepoint [2] 258360 0
Up to 24 hours post dose
Secondary outcome [1] 264093 0
To measure the serum cortisol levels in order to evaluate it as a potential marker of central nervous system effects of BNC210
Timepoint [1] 264093 0
Pre-dose, 05, 1, 1.5, 2, 2.5, 3 hours post-dose

Eligibility
Key inclusion criteria
1. Adult males 18-65 years
2. Good general health without significant renal, hepatic, cardiac or respiratory disease
3. Good general mental health as determined by scores on the Symptom Checklist 90-R
4. Agree to and be able to sign informed consent form
5. Have suitable venous access for blood sampling
6. Body mass index (BMI) within 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 - creatine clearance less than 90 mL/min (Cockcroft-Gault method)
2. Laboratory value at screening outside the normal range, unless it is judged by investigator as not clinically significant after appropriate evaluation
3. Score of more than 2 standard deviations from the mean on any of the key 9 scales in the Symptom Checklist -90 - Revised (SCL-90-R)
4. Any medical condition that in the opinion of the investigator may adversely impact on ability to complete the study
5. Plasma Aspartate transaminase (AST), alanine transaminase (ALT), Alkaline phosphatase (ALP) tests in excess of 1.5 times the upper limit of normal
6. Laboratory evidence of clinically significant serum iron deficiency
7. History of severe allergic or anaphylactic drug-related reactions
8. Current (within last 6 months) clinically significant psychiatric disorder including anxiety or depression
9. Concurrent use of medication ona regular or daily basis
10. Participation in another clinical trial of an investigational agent within 30 days of study entry
11. Known history of past or present infection with hepatitis C virus, hepatitis B or human immuno-deficiency virus (HIV)
12. Clinically significant abnormal electrocardiogram (ECG) (12 lead) at screening visit or prior to dosing on Day 1 as determined by the investigator
13. Marked prolongation of the QTcB interval (ie repeated demonstration of QTcB interval >430 for males)at screening or prior to dosing on Day 1
14. Significant history of illicit drug or alcohol use or abuse within 1 year of screening
15. Any alcohol use with 24 hrs prior to dosing on Day 1
16. Unwillingness or inability to comply with requirements of the protocol
17. Blood donation (1 unit or more) within 1 month prior to screening
18. Smoke >5 cigarettes per day
19. Previous enrolment in study BNC210.001

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking 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
Date of first participant enrolment
Anticipated
5/05/2010
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] 256915 0
Self funded/Unfunded
Name [1] 256915 0
Bionomics Limited
Country [1] 256915 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
31 Dalgleish Street
Thebarton
SA 5031
Country
Australia
Secondary sponsor category [1] 256185 0
None
Name [1] 256185 0
Address [1] 256185 0
Country [1] 256185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258919 0
Research Ethics Committee of the Royal Adelaide Hospital
Ethics committee address [1] 258919 0
Ethics committee country [1] 258919 0
Australia
Date submitted for ethics approval [1] 258919 0
Approval date [1] 258919 0
28/04/2010
Ethics approval number [1] 258919 0
100409

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

Contacts
Principal investigator
Name 31126 0
Address 31126 0
Country 31126 0
Phone 31126 0
Fax 31126 0
Email 31126 0
Contact person for public queries
Name 14373 0
Sue O'Connor
Address 14373 0
31 Dalgleish St
Thebarton
SA 5031
Country 14373 0
Australia
Phone 14373 0
+61 8 8354 6100
Fax 14373 0
Email 14373 0
[email protected]
Contact person for scientific queries
Name 5301 0
Sue O'Connor
Address 5301 0
31 Dalgleish St
Thebarton
SA 5031
Country 5301 0
Australia
Phone 5301 0
+61 8 8354 6100
Fax 5301 0
Email 5301 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.