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Trial registered on ANZCTR


Registration number
ACTRN12619001180101
Ethics application status
Approved
Date submitted
7/08/2019
Date registered
20/08/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
20/08/2019
Date results information initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The pharmacokinetics and clinical tolerability of ascending single doses of an oral tablet formulation of BNC210 in healthy male volunteers
Scientific title
The pharmacokinetics and clinical tolerability of ascending single doses of an oral tablet formulation of BNC210 in healthy male volunteers
Secondary ID [1] 298684 0
BNC210.010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 313581 0
Trauma-and stressor-related disorders 314018 0
Condition category
Condition code
Mental Health 312016 312016 0 0
Anxiety
Mental Health 312017 312017 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Every participant will receive each dose of BNC210 described below in three separate dose periods, with a 5-day washout period between each dose:

Dose period 1 - BNC210 600 mg, single dose, oral tablet
Dose period 2 - BNC210 900 mg, single dose, oral tablet
Dose period 3 - BNC210 1200 mg, single dose, oral tablet
Intervention code [1] 314955 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320656 0

To compare the pharmacokinetic profile of ascending doses of a tablet formulation of BNC210
Timepoint [1] 320656 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 and 24 hours post-dose
Secondary outcome [1] 372356 0
To assess the safety and tolerability of ascending doses of a tablet formulation of BNC210
Timepoint [1] 372356 0
Safety assessments will include:
- adverse event reporting (throughout study)
- physical examination (screening, day -1 and day 2 of each dose period, follow up)
- routine laboratory investigations (screening, day -1 of each dose period, follow up)
- vital signs evaluations (screening, regularly throughout each dose period, follow up)

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/m2.
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. A highly effective method of birth control includes vasectomy
or the use of a condom in combination with barrier methods, hormonal birth control or intrauterine device by the female partner.
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 >440 msec 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/e-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
Phase 1
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
Recruitment hospital [1] 14242 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 27235 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 303234 0
Commercial sector/Industry
Name [1] 303234 0
Bionomics Limited
Address [1] 303234 0
31 Dalgleish Street
Thebarton
SA 5031
Country [1] 303234 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
31 Dalgleish Street
Thebarton
SA 5031
Country
Australia
Secondary sponsor category [1] 303239 0
None
Name [1] 303239 0
Address [1] 303239 0
Country [1] 303239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303780 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 303780 0
129 Glen Osmond Road
Eastwood SA
5063
Ethics committee country [1] 303780 0
Australia
Date submitted for ethics approval [1] 303780 0
Approval date [1] 303780 0
06/08/2019
Ethics approval number [1] 303780 0

Summary
Brief summary
Bionomics Limited is developing BNC210 for the treatment of anxiety, and trauma- and stressor-related, disorders including Post-Traumatic Stress Disorder (PTSD). This single-centre study, will evaluate the pharmacokinetic profile, as well as the safety and tolerability, of single ascending doses of BNC210 in five healthy male volunteers. Participants will receive single doses of 600 mg, 900 mg and 1200 mg BNC210 as a tablet formulation, during three separate dose periods. There will be a minimum 5 day washout period between each dose period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94778 0
Dr Thomas Polasek
Address 94778 0
CMAX Clinical Research Pty. Ltd.
Level 5, 18a North Terrace
Adelaide
SA 5000
Country 94778 0
Australia
Phone 94778 0
+61 8 7088 7900
Fax 94778 0
Email 94778 0
tom.polasek@certara.com
Contact person for public queries
Name 94779 0
Dr Thomas Polasek
Address 94779 0
CMAX Clinical Research Pty. Ltd.
Level 5, 18a North Terrace
Adelaide
SA 5000
Country 94779 0
Australia
Phone 94779 0
+61 8 7088 7900
Fax 94779 0
Email 94779 0
tom.polasek@certara.com
Contact person for scientific queries
Name 94780 0
Dr Thomas Polasek
Address 94780 0
CMAX Clinical Research Pty. Ltd.
Level 5, 18a North Terrace
Adelaide
SA 5000
Country 94780 0
Australia
Phone 94780 0
+61 8 7088 7900
Fax 94780 0
Email 94780 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
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