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Trial registered on ANZCTR


Registration number
ACTRN12615001285549
Ethics application status
Approved
Date submitted
23/11/2015
Date registered
25/11/2015
Date last updated
21/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluative study to assess the safety of Nanocelle (Trademark) Atorvastatin Formulation Administered Oro-buccally (by mouth spray) in Healthy Adult Volunteers.
Scientific title
A Phase 0, Multi-dose, Open-label, Clinical Trial To Investigate The Safety of a Micro-dose of a Nanocelle (Trademark) Atorvastatin Formulation Administered Oro-buccally in Healthy Adult Volunteers
Secondary ID [1] 287847 0
Nil known
Universal Trial Number (UTN)
U1111-1176-3474
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidaemia 296732 0
Condition category
Condition code
Cardiovascular 296972 296972 0 0
Other cardiovascular diseases
Metabolic and Endocrine 297082 297082 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinical study will investigate the tolerability and safety of Nanocelle Atorvastatin. The patient will be instructed to initially administer oro-buccally 0.01 mg of atorvastatin per spray once a day. Administration of additional sprays will be a maximum of 1 spray over 24 hours for a total of 7 days..

Schedule Dose: Day 1: Administer 1 spray oro-buccally 5 minutes prior to P.K collection, a maximum dose of 0.01mg/day.
Schedule Dose: Days 2–7: Administer 1 spray once a day [maximum day 1–7 dose 0.01 mg / day]


Duration: 7 Days
Methods and tools used to monitor side effects and toxicity 1) Participant diary
Intervention code [1] 293312 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296681 0
To evaluate to safety and tolerability of Micellised atorvastatin. Tests will be performed include: liver function test, full blood evaluation, blood lipids, urea and electrolytes, blood pressure, ECG, pharmacokinetic data, SF-12 general health questionnaire, and participant diary to capture adverse events.
Timepoint [1] 296681 0
Safety and tolerability will be assessed during an acute phase (day 1, 0-24 hours) and a delayed phase (Day 2-Day 7).
Blood test(Liver function test, full blood evaluation, blood lipids, urea and electrolytes) will be performed at baseline, day 2 and day 7.
Pharmacokinetic blood samples will be taken at baseline, and after dosing (30 minutes, 1 hour, 2 hour, 4 hour and Day 7).
ECGs are performed at screening, Day 1 and Day 7
Blood pressure test will be performed at baseline, and after dosing (30 minutes, 1 hour, 2 hour, 4 hour and Day 7).
SF-12 general health questionnaire will be performed daily from Day 1 to Day 7.
Secondary outcome [1] 319109 0
Participant adherence to the intervention
Timepoint [1] 319109 0
Participant is given a medication diary to capture daily dosing for 7 days.

Eligibility
Key inclusion criteria
1) Participants greater than or equal 18 years of age up to and including 80 years ago at time of entry on study 2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment 3) Participants agree to undergo venepuncture on multiple occasions 4) Participants agree to adhere to the study protocol 5) Hyperlipidaemic 6) Normal ECG reading QTcF < 450 msec 7) No history of statins reaction
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs 2) Previous history of rhabdomyolysis 3) Alcohol abuse 4) The use of any illicit drugs 5) Pregnancy or nursing an infant 6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant 7) Elevated liver enzymes 2x normal limits

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
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety
Statistical methods / analysis
All data will be summarized descriptively using n, mean, median, standard deviation and 95% confidence intervals for continuous data, and frequency and percent for categorical data. All tests will be conducted two-sided and p values of less than 0.05 will be considered statistically significant. Data will be analysed on an intent-to-treat basis using STATA MP v13 for Mac. All available data used will be treated as for intention–to–treat analyses. All analyses will be conducted with software from STATA for windows version 13.0 [College Station, Texas] and SPSS for windows, version 21 (SPSS Inc, Chicago).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/11/2015
Actual
Date of last participant enrolment
Anticipated
14/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292438 0
Commercial sector/Industry
Name [1] 292438 0
Medlab Pty Ltd
Country [1] 292438 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Pty Ltd
Address
66 McCauley St, Alexandria NSW 2015
Country
Australia
Secondary sponsor category [1] 291131 0
None
Name [1] 291131 0
N/A
Address [1] 291131 0
N/A
Country [1] 291131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293897 0
National Institute of Integrative Medicine
Ethics committee address [1] 293897 0
21 Burwood Rd, Hawthorn VIC 3122
Ethics committee country [1] 293897 0
Australia
Date submitted for ethics approval [1] 293897 0
Approval date [1] 293897 0
15/09/2015
Ethics approval number [1] 293897 0
0028E_2015

Summary
Brief summary
This clinical trial aims to explore the safety and tolerability of Atorvastatin Oro-buccal Spray Micelle.
Who is it for? All participants who are aged 18 years or over with no allergic reactions to statins
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61458 0
Prof Luis Vitetta
Address 61458 0
Medlab Pty Ltd
66 McCauley St.
Alexandria, NSW 2015
Country 61458 0
Australia
Phone 61458 0
+61 (02) 8094 1939
Fax 61458 0
Email 61458 0
[email protected]
Contact person for public queries
Name 61459 0
Tony Nguyen
Address 61459 0
Medlab Pty Ltd
66 McCauley St.
Alexandria, NSW 2015
Country 61459 0
Australia
Phone 61459 0
+61 (02) 8188 0311
Fax 61459 0
Email 61459 0
[email protected]
Contact person for scientific queries
Name 61460 0
Luis Vitetta
Address 61460 0
Medlab Pty Ltd
66 McCauley St.
Alexandria, NSW 2015
Country 61460 0
Australia
Phone 61460 0
+61 (02) 8094 1939
Fax 61460 0
Email 61460 0
[email protected]

No information has been provided regarding IPD availability


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.