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Trial registered on ANZCTR


Registration number
ACTRN12618001381279p
Ethics application status
Submitted, not yet approved
Date submitted
13/08/2018
Date registered
16/08/2018
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A single centre, double blind, randomised, parallel group, single dose signal study of R-107 in participants with DSM-5 specific phobia
Scientific title
A single centre, double blind, randomised, parallel group, single dose signal study of R-107 in particpants with DSM-5 specific phobia, to spiders.
Secondary ID [1] 295775 0
None
Universal Trial Number (UTN)
U1111-1216-1926
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Specific phobia to spiders 309217 0
Condition category
Condition code
Mental Health 308091 308091 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be administered a single dose of 120mg R-107 or matching placebo tablets. The dose will consist of 2 identical tablets, each tablet contains 60mg of R-107 (or placebo).
Participants will be closely observed at the time of dosing and a mouth check will take place immediately after swallowing. Participants will take 240ml water with the dose. Tablets are to be swallowed whole, both at the same time. Participants will be dosed individually so each participant is closely observed.
Intervention code [1] 312121 0
Treatment: Drugs
Comparator / control treatment
This study will be placebo-controlled in a 1:1 ratio. Placebo will consist of 2 tablets administered in a single dose.
R-107 is white, oval, biconvex, film-coated tablet. R-107 is tamper proof therefore mitigating any potential for abuse.
The R-107 placebo tablets composition is Polyethylene Oxide 96%, Magesium Stearate 1%, Opadry white Y-1-7000 3%, coated in the same film as the R-107 active tablet making it identical in appearance.
Control group
Placebo

Outcomes
Primary outcome [1] 307073 0
Primary outcome will be change in BAT score (Behaviour Avoidance Task) from baseline (pre-dose) to 3 hours post-dose.
Timepoint [1] 307073 0
3 hours post-dose.
Secondary outcome [1] 350555 0
Change in BAT score 72 hours post-dose. Paticipants will complete the same assessment approximately 72 hours after the single dose administration.
Timepoint [1] 350555 0
Day 3 (+ 72 hours post-dose)
Secondary outcome [2] 350556 0
Safety and tolerability of R-107 as measured by adverse event reporting after dosing, and change in vital signs, laboratory results, ECG, CADSS and C-SSRS scores.
Timepoint [2] 350556 0
3 hours post-dose, 72 hours post-dose and Day 7 / Study Exit
Secondary outcome [3] 350557 0
Pharmacokinetic effect as measured by change in PK level from pre-dose (within 1 hour prior to dosing) and 3 hours post-dose concentration. Blood samples will be assayed for ketamine and norketamine using a fully validated LCMS/MS analytical method. Serum assay has been developed.
Timepoint [3] 350557 0
Time point of the PK endpoint is 3 hours post-dose. There will only be 2 PK samples drawn - one immediately prior to the dose, the second at 3 hours after the dose.
Secondary outcome [4] 350558 0
Anxiety self-ratings as measured by Fear Questionnaire Item 18, Fear of Spiders Questionnaire and anxiety Visual Analog Scale.
Timepoint [4] 350558 0
3 hours and 72 hours after dosing

Eligibility
Key inclusion criteria
Able to provide informed consent; able and willing to comply with study requirements including clinic visits; male or female (not pregnant or lactating); aged 18-40 years; BMI 18-35kg/m2; diagnosed with DSM-5 specific phobia to spiders for at least 12 months; able to swallow tablets; score >95 on Fear of Spiders questionnaire (at screening visit)
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically significant medical history or medications; clinically significant illness in last 30 days or febrile illness in last 5 days prior to Day 1; history of schizophrenia or other psychotic illness; currently taking benzodiazepines; prior exposure to ketamine; history of drug or alcohol abuse or dependency, including ketamine or it's excipients; clinically significant abnormal ECG or laboratory test result during screening; pregnant or breastfeeding female, or not using effective contraception; involvement in another clinical drug or device trial or less than 60 days since last participation; not having a GP or do not consent to GP being contacted; not able to understand information provided about the study, or not able to be compliant with required procedures; malignancy in last 5 years; employee/family member of sponsor, or study site.

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)
This study will be double-blind. Randomisation will be by computer programme. Randomisation code list will not be available for any site staff or any sponsor staff directly involved in the study, eg CRA, Clinical Trial Manager. Unblinded team members will be involved only in this process and will not have any further involvement in the study procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by permuted block randomisation generated by computer. Randomisation codes will be assigned sequentially as participants become eligible. Each participant will be allocated to one of the 2 treatment arms (active or placebo) according to the sequential randomised list generated. A blinded treatment code will correspond to a pre-labelled medication kit which will then be administered to the participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis
12 participants will be randomised in a 1:1 schema. This is a signal study and this number is typical for this type of phase 1 study, it is not based on any formal power calculations. All participants receiving treatment will be included in demographic and safety data. Safety data will include adverse events, serious adverse events, laboratory assessments, vital signs and ECG data. PK analysis for ketamine and norketamine will be completed at +3hr concentration. Multiple linear regression analysis will be used to investigate changes in BAT and anxiety scores, with the relationship between plasma concentrations of ketamine & norketamine and change in BAT scores evaluated by regression analysis.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Sponsor decision due to concurrent projects to be 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 outside Australia
Country [1] 20751 0
New Zealand
State/province [1] 20751 0
Dunedin

Funding & Sponsors
Funding source category [1] 300366 0
Commercial sector/Industry
Name [1] 300366 0
Douglas Pharmaceuticals Ltd
Address [1] 300366 0
Te Pai Place, Henderson, Auckland 0610, New Zealand
Country [1] 300366 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Douglas Pharmaceuticals Ltd
Address
Te Pai Place, Henderson, Auckland 0610, New Zealand
Country
New Zealand
Secondary sponsor category [1] 299813 0
None
Name [1] 299813 0
Address [1] 299813 0
Country [1] 299813 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301178 0
Southern Health and Disability Ethics Committee, NZ
Ethics committee address [1] 301178 0
Sudima Hotel, Christchurch Airport, 550 Memorial Drive, Christchurch, 8053, NZ
Ethics committee country [1] 301178 0
New Zealand
Date submitted for ethics approval [1] 301178 0
28/06/2018
Approval date [1] 301178 0
Ethics approval number [1] 301178 0

Summary
Brief summary
This is a single centre, double blind, randomised, parallel group, single-dose signal study of R-107 in participants with DSM-5 specific phobia to spiders. 12 participants will be randomised to receive a single dose of either R-107 or placebo. The hypothesis is that compared with placebo, R-107 will reduce anxiety self-ratings and avoidance behaviour associated with exposure to a phobic object (spider) in participants known to have a specific phobia according to DSM-5 criteria. Participants will complete several assesments prior to receiveing the dose, and then again 3 hours and 72 hours later.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86114 0
Prof Paul W Glue
Address 86114 0
Fraser Building
University of Otago School of Psychological Medicine,
464 Cumberland Street
Dunedin, 9016
New Zealand
Country 86114 0
New Zealand
Phone 86114 0
+6434779669
Fax 86114 0
Email 86114 0
paul.glue@otago.ac.nz
Contact person for public queries
Name 86115 0
Ms Rhona Macdonald
Address 86115 0
Douglas Pharmaceuticals Ltd
2 Te Pai Place
Henderson 0610
Auckland
Country 86115 0
New Zealand
Phone 86115 0
+6498350660
Fax 86115 0
Email 86115 0
rhonam@douglas.co.nz
Contact person for scientific queries
Name 86116 0
Prof Paul W Glue
Address 86116 0
Fraser Building
University of Otago School of Psychological Medicine,
464 Cumberland Street
Dunedin, 9016,
New Zealand
Country 86116 0
New Zealand
Phone 86116 0
+6434779669
Fax 86116 0
Email 86116 0
paul.glue@otago.ac.nz

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 collected
What supporting documents are/will be available?
No other documents available
Summary results
No Results