Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000952741
Ethics application status
Approved
Date submitted
30/06/2022
Date registered
6/07/2022
Date last updated
9/11/2022
Date data sharing statement initially provided
6/07/2022
Date results information initially provided
9/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study testing wafers containing different doses of dexmedetomidine in healthy volunteers.
Scientific title
An open label, four-way crossover study to evaluate the pharmacokinetic effects of different dosages of a novel sublingual dexmedetomidine wafer compared to intravenous dexmedetomidine, in healthy volunteers under fasted conditions.
Secondary ID [1] 307459 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation 326847 0
Condition category
Condition code
Mental Health 324061 324061 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a single dose of sublingual dexmedetomidine wafer 30, 50 and 100mcg, with a minimum washout of 44 hours between each dose. Administration under clinical monitoring. Staff will perform a disintegration check 10 minutes after administration.
Intervention code [1] 323913 0
Treatment: Drugs
Comparator / control treatment
Dexmedetomidine 20 mcg injection administered once via intravenous route
Control group
Active

Outcomes
Primary outcome [1] 331847 0
To determine the pharmacokinetics effects of different dosages of dexmedetomidine wafers administered via sublingual route vs. intravenous dexmedetomidine. Standard non-compartmental analysis methods will be used to obtain PK variables for dexmedetomidine such as Cmax, AUCinf, CL, Tmax, Cmax, Vz, and t1/2.
Timepoint [1] 331847 0
Pharmacokinetic blood samples will be collected pre-dose and at 5, 10, 15, 20, 30, 40, 50 mins and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose.
Secondary outcome [1] 411388 0
To determine safety and tolerability of dexmedetomidine wafers administered via sublingual route by monitoring physical status through vital signs (blood pressure[ [assessed by sphygmomanometer], pulse [measured by pulse oximeter], respirations [measured by 60 second manual count], and temperature), physical exams, safety laboratory testing (hematology and chemistry) and level of sedation (using the Richmond Agitation Sedation Scale).
Timepoint [1] 411388 0
Vital signs will be measured pre-dose, at 30 minutes, and at 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00 and 24.00 hours post-dose during each period
Physical exams will be conducted at screening, check-in, and 24 hours post-dose Treatment D.
Safety laboratory testing will be completed at screening, pre-dose and 24 hours post-dose Treatment D.
Sedation scores will be measured pre-dose and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 12.00, and 24.00 hours post-dose during each period.
Secondary outcome [2] 411475 0
Safety and tolerability will be measured by adverse events reported by and observed by staff and will be reported using standard MedDRA terminology. Investigator will determine relationship of adverse events to study medication. Known adverse effects associated with the use of dexmedetomidine include hypo or hypertension and bradycardia.
Timepoint [2] 411475 0
Adverse events will be collected from time of initial dose of Treatment A through the follow-up phone call. The follow-up phone call will occur 3 days (+/- 1 day) post discharge from the inpatient portion of the study.

Eligibility
Key inclusion criteria
1. Good general health.
2.. Willing and able to provide informed consent for study participation.
3. Has suitable venous access for blood sampling.
4. Body weight a minimum of 50 kg and BMI within the range of 19.0-28.0 kg/m2 (inclusive).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of or current serious, clinically significant, or unstable medical condition which, in the opinion of the Investigator, could affect safety or integrity of study results.
2. Presence or history of malignancy (exception: successfully treated basal cell carcinoma is not an exclusion).
3. Clinically significant abnormal 12-lead ECG or history of clinically significant cardiac dysrhythmias, including bradycardia.
4. Clinically significant orthostatic vital signs at screening or vital signs on admission day.

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
29/08/2022
Actual
26/09/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
4/10/2022
Date of last data collection
Anticipated
31/10/2022
Actual
8/10/2022
Sample size
Target
14
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311730 0
Commercial sector/Industry
Name [1] 311730 0
iX Biopharma Pty Ltd
Country [1] 311730 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
iX Biopharma Pty Ltd
Address
iX Biopharma Pty Ltd, 24 Augusta Street Willeton, WA 6155
Country
Australia
Secondary sponsor category [1] 313190 0
None
Name [1] 313190 0
None
Address [1] 313190 0
None
Country [1] 313190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311179 0
Bellberry Limited HREC
Ethics committee address [1] 311179 0
123 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 311179 0
Australia
Date submitted for ethics approval [1] 311179 0
13/07/2022
Approval date [1] 311179 0
26/08/2022
Ethics approval number [1] 311179 0

Summary
Brief summary
This is an open-label, four-way crossover, fasted pharmacokinetic study in healthy volunteers.
The screening visit will include a physical exam, vital signs collection, an electrocardiogram, safety laboratory sampling and urinalysis to determine suitability for inclusion into the study.
Qualified study participants will be admitted the evening prior (Day -1) to scheduled dosing. Each participant will receive a single dose of study medication per dosing day. There will be a minimum washout of 44 hours between doses.
Participants will remain inpatient for the entire dosing/washout period and will be discharged 24 hours after Treatment D.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120230 0
Dr Sam Francis
Address 120230 0
Nucleus Network, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne 3004, Victoria
Country 120230 0
Australia
Phone 120230 0
+61 03 8593 9800
Fax 120230 0
Email 120230 0
s.francis@nucleusnetwork.com.au
Contact person for public queries
Name 120231 0
Ms Nucleus Network Melbourne
Address 120231 0
Nucleus Network, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne 3004, Victoria
Country 120231 0
Australia
Phone 120231 0
+61 1800 243 733
Fax 120231 0
Email 120231 0
melbourne@nucleusnetwork.com
Contact person for scientific queries
Name 120232 0
Dr Sam Francis
Address 120232 0
Nucleus Network, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne 3004, Victoria
Country 120232 0
Australia
Phone 120232 0
+61 03 8593 9800
Fax 120232 0
Email 120232 0
s.francis@nucleusnetwork.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not required


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.