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Trial registered on ANZCTR


Registration number
ACTRN12618001197224
Ethics application status
Approved
Date submitted
9/07/2018
Date registered
18/07/2018
Date last updated
5/12/2018
Date data sharing statement initially provided
5/12/2018
Date results information initially provided
5/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A single dose, cross-over pharmacokinetic study comparing oral formulations of BNC210 in healthy male volunteers
Scientific title
A single dose, cross-over pharmacokinetic study comparing oral formulations of BNC210 in healthy male volunteers
Secondary ID [1] 295315 0
Protocol Number: BNC210.009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 308508 0
Trauma and stressor related disorders 308780 0
Condition category
Condition code
Mental Health 307480 307480 0 0
Anxiety
Mental Health 307481 307481 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - BNC210 300mg oral suspension, fasted, single dose
Arm 2 - BNC210 2 x 150mg oral tablet, fasted, single dose
Arm 3- BNC210 2 x 150mg oral tablet, fed, single dose
The wash out period between each dose will be at least 5 days. Participants are randomly assigned to each Arm, but will all participate in each Arm once. Participants in Arm 1 and Arm 2 will fast for a minimum of 10 hours pre-dose, this fast will not include water except from 2 hours pre-dose. Participants in Arm 3 will fast for 9.5 hours and then consume a High Fat breakfast in its entirety within the 30 minutes prior to dosing. This fast will not include water except from 2 hours pre-dose. All investigational product will be monitored via accountability logs, and each dose will be administered and observed by study personnel.
Intervention code [1] 301643 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Active

Outcomes
Primary outcome [1] 306454 0
To compare the pharmacokinetic profile of suspension (fasted) and tablet (fasted and fed) oral formulations of BNC210.
Timepoint [1] 306454 0
PK blood samples will be taken at the following time points for each treatment arm: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3, 4, 6, 8, 12, 18 and 24 hours post-dose.
Secondary outcome [1] 348601 0
To assess the safety and tolerability of suspension and tablet oral formulations of BNC210.
Timepoint [1] 348601 0
Scheduled adverse event (AE) probes will occur at the following time points for each treatment arm: 1, 2, 4, 6, 8, 12 and 24 hours post-dose. Spontaneous AE reporting will also occur throughout the study.
Physical examinations will occur at screening, and for each treatment arm on the day before dosing and 24 hours post-dose.
Routine laboratory tests will be performed at screening, on the day before dosing for each treatment arm, and 24 hours post-dose for the last treatment arm.
Vital sign evaluations will be performed at screening, and at the following time points for each treatment arm: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose.

Eligibility
Key inclusion criteria
1. Agree to and be capable of signing informed consent form.
2. Adult males aged 18-65 years (inclusive).
3. Body mass index within the range of 18-30 kg/m^2.
4. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.
5. Have suitable venous access for blood sampling.
6. Agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 3 months after the last dose of study drug.
Minimum age
18 Years
Maximum age
65 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any medical condition that in the opinion of the Investigator may adversely impact on the participant’s ability to complete the study.
2. Renal impairment as evidenced by estimated creatinine clearance, measured by the Cockcroft-Gault method of less than 90 mL/min.
3. 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.
4. Plasma AST (aspartate transaminase), ALT (alanine transaminase), and ALP (alkaline phosphatase) tests in excess of 1.5 times the upper limit of normal.
5. History of severe allergic or anaphylactic drug-related reactions.
6. Known past or present mental health disorder.
7. Concurrent use of any prescription medication, over the counter medication or complementary / alternative medication within 2 weeks prior to dosing (single or multiple doses).
8. Consumption of grapefruit, grapefruit juice, red wine or St. John’s Wort within 2 weeks prior to first dose.
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 (HBV) or human immunodeficiency virus (HIV).
11. Clinically significant abnormal ECG (12-lead) at the Screening Visit as determined by the Investigator.
12. Participants who have a marked prolongation of the QTcF corrected interval (i.e., repeated demonstration of a QTcF interval >460 msec for females or >440 msec for males) at Screening.
13. Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit.
14. 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 participant returning for visits on schedule.
15. Blood donation (1 unit or more) within 1 month prior to the Screening Visit.
16. Smoked cigarettes, tobacco and/or tetrahydrocannabinol containing products within 2 weeks prior to first dose.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 299905 0
Commercial sector/Industry
Name [1] 299905 0
Bionomics Limited
Address [1] 299905 0
31 Dalgleish Street
Thebarton, SA 5031
Country [1] 299905 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
31 Dalgleish Street
Thebarton, SA 5031
Country
Australia
Secondary sponsor category [1] 299272 0
Commercial sector/Industry
Name [1] 299272 0
CPR Pharma Services Pty. Ltd.
Address [1] 299272 0
28 Dalgleish Street
Thebarton, SA 5031
Country [1] 299272 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300774 0
Bellberry Human Research Ethics Committee D [EC00444]
Ethics committee address [1] 300774 0
129 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 300774 0
Australia
Date submitted for ethics approval [1] 300774 0
04/06/2018
Approval date [1] 300774 0
02/07/2018
Ethics approval number [1] 300774 0
2018-05-388

Summary
Brief summary
BNC210 is being developed for the treatment of anxiety, and trauma- and stressor-related,
disorders including post-traumatic stress disorder (PTSD). This three-way crossover single dose study will compare the pharmacokinetic profiles of oral suspension and tablet formulations of BNC210.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84774 0
Dr Thomas Polasek
Address 84774 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace
Adelaide SA 5000
Country 84774 0
Australia
Phone 84774 0
+61 458 162 715
Fax 84774 0
Email 84774 0
Tom.Polasek@certara.com
Contact person for public queries
Name 84775 0
Dr Thomas Polasek
Address 84775 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace
Adelaide SA 5000
Country 84775 0
Australia
Phone 84775 0
+61 458 162 715
Fax 84775 0
Email 84775 0
Tom.Polasek@certara.com
Contact person for scientific queries
Name 84776 0
Dr Thomas Polasek
Address 84776 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace
Adelaide SA 5000
Country 84776 0
Australia
Phone 84776 0
+61 458 162 715
Fax 84776 0
Email 84776 0
Tom.Polasek@certara.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No data sharing plan was in place at the time of the study.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary