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Trial registered on ANZCTR


Registration number
ACTRN12621000125820
Ethics application status
Approved
Date submitted
7/12/2020
Date registered
8/02/2021
Date last updated
19/05/2021
Date data sharing statement initially provided
8/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multiple Dose Study Evaluating the Pharmacokinetics of an Oral Tablet Formulation of BNC210 in Healthy Volunteers
Scientific title
A Multiple Dose Study Evaluating the Pharmacokinetics of an Oral Tablet Formulation of BNC210 in Healthy Volunteers
Secondary ID [1] 302842 0
BNC210.011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 319819 0
Trauma and- stressor-related disorders 319820 0
Condition category
Condition code
Mental Health 317754 317754 0 0
Anxiety
Mental Health 317755 317755 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In Dose Period 1, each participant will receive a total of 12 doses of an oral tablet formulation of BNC210 over a 7 day period as follows:
- single dose of 900 mg BNC210 on Day 1
- twice daily doses of 900 mg BNC210 on Days 2-6
- single 900 mg dose of BNC210 on Day 7

Based on the analysis of pharmacokinetic and safety data from Dose Period 1, a second dose level may be assessed (Dose Period 2) using either a 1,125 mg OR a 1,350 mg dose of BNC210. Dose Period 2 will follow the same dosing schedule as described for Dose Period 1.

A separate group of 10 participants will be enrolled into each Dose Period
Intervention code [1] 319125 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325781 0
To evaluate the pharmacokinetic profile at steady state of a tablet formulation of BNC210.

Parameters will include but not be limited to Cmax, Tmax, AUC, t1/2
Timepoint [1] 325781 0
PK blood samples will be taken at the following time points
Day 1-2:
• Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3, 3.5, 4, 5, 6, 8, 12 (Day 1) and 24 hours post-dose (Day 2)
Day 3-6:
• Pre-dose only
Day 7-8:
• Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3, 3.5, 4, 5, 6, 8, 12 (Day 7) and 24 hours post-dose (Day 8)
Secondary outcome [1] 389123 0
To compare gender differences in the pharmacokinetic profile of a tablet formulation of BNC210.

Parameters will include but not be limited to Cmax, Tmax, AUC, t1/2
Timepoint [1] 389123 0
Same as primary timepoint
Secondary outcome [2] 389124 0
To assess the safety and tolerability of multiple doses of a tablet formulation of BNC210.

This outcome will be assessed by the monitoring of adverse events, performing physical examinations, routine laboratory investigations and vital signs evaluations.
Timepoint [2] 389124 0
Day 1-2:
• Pre-dose, 1, 2, 4, 6, 8, 12 (Day 1) and 24 hours post-dose (Day 2)
Day 3-6:
• Daily
Day 7-8:
• Pre-dose, 1, 2, 4, 6, 8, 12 (Day 7) and 24 hours post-dose (Day 8)
Day 14 (Follow Up)

Eligibility
Key inclusion criteria
1. Agree to and be capable of signing informed consent form.
2. Adult males or females aged 18-65 years (inclusive) at the time of providing informed consent.
3. Body mass index within the range of 18-30 kg/m2 at screening
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. Ability to swallow tablets
7. Females participants of childbearing potential who are not currently pregnant of breast feeding. Females not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months prior to Screening and confirmed by follicle stimulating hormone (FSH) levels in menopausal range at Screening).
8. Agree to abstain from sexual intercourse or use a highly effective method of birth control if participant or partner of participant is of childbearing potential, for the duration of the study and for 3 months after the last dose of study drug. Highly effective methods of birth control include vasectomy, the use of a condom in combination with barrier methods, hormonal birth control (except oral contraception – see exclusion criterion 12) or intrauterine device. Requirement for contraception can be waived in certain circumstances (i.e. same sex relationships) if approved by the Sponsor.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
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 at screening or Day -1.
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 first dose.
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) or a positive test for HCV, HBV or HIV at screening.
11. Females who are pregnant, nursing, or intend to become pregnant during the study or within 3 months of their last dose of BNC210, or any males who plan to father/conceive a child within 3 months of their last dose of BNC210.
12. Females who are currently taking oral hormonal contraception (except progestogen only contraception (e.g., “minipill”), including levonorgestrel-releasing intrauterine devices)
13. Clinically significant abnormal ECG (12-lead) at the Screening Visit as determined by the Investigator.
14. Participants who have a marked prolongation of the QTcF corrected interval (i.e., repeated demonstration of a QTcF interval >450 msec for males and >470 msec for females at Screening.
15. Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit.
16. 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.
17. Blood donation (1 unit or more) within 1 month prior to the Screening Visit.
18. 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
Open (masking not used)
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
18/01/2021
Date of last participant enrolment
Anticipated
Actual
2/02/2021
Date of last data collection
Anticipated
Actual
22/02/2021
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18075 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 32063 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 307262 0
Commercial sector/Industry
Name [1] 307262 0
Bionomics Limited
Country [1] 307262 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bionomics Limited
Address
31 Dalgleish Street
Thebarton
SA 5031
Country
Australia
Secondary sponsor category [1] 307885 0
None
Name [1] 307885 0
Address [1] 307885 0
Country [1] 307885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307360 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 307360 0
Ethics committee country [1] 307360 0
Australia
Date submitted for ethics approval [1] 307360 0
Approval date [1] 307360 0
20/11/2020
Ethics approval number [1] 307360 0

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

Contacts
Principal investigator
Name 106954 0
Dr Thomas Polasek
Address 106954 0
CMAX Clinical Research Pty. Ltd.
Level 5, 18a North Terrace
Adelaide
SA 5000
Country 106954 0
Australia
Phone 106954 0
+61 8 7088 7900
Fax 106954 0
Email 106954 0
tom.polasek@certara.com
Contact person for public queries
Name 106955 0
Thomas Polasek
Address 106955 0
CMAX Clinical Research Pty. Ltd.
Level 5, 18a North Terrace
Adelaide
SA 5000
Country 106955 0
Australia
Phone 106955 0
+61 8 7088 7900
Fax 106955 0
Email 106955 0
tom.polasek@certara.com
Contact person for scientific queries
Name 106956 0
Thomas Polasek
Address 106956 0
CMAX Clinical Research Pty. Ltd.
Level 5, 18a North Terrace
Adelaide
SA 5000
Country 106956 0
Australia
Phone 106956 0
+61 8 7088 7900
Fax 106956 0
Email 106956 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 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.