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Trial registered on ANZCTR


Registration number
ACTRN12615000304538
Ethics application status
Approved
Date submitted
7/02/2015
Date registered
1/04/2015
Date last updated
7/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pharmacokinetic and Safety Study of the Chrono Nicotine Replacement Therapy System in male smokers.
Scientific title
A pharmacokinetic and safety study of the Chrono Nicotine Replacement Therapy System in male smokers.
Secondary ID [1] 286126 0
PK2014-001
Universal Trial Number (UTN)
U1111-1167-0349
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cigarette addiction 294132 0
Condition category
Condition code
Mental Health 294449 294449 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nicotine Replacement Therapy System
6 doses of 6% nicotine formulation over 24 hours. Doses delivered at T0, T1, T6, T7, T12, T13
transdermally administered using the Chrono IDC 5 device through a patch. Pharmacokinetic analysis and skin tolerability using a 7 point visual scale will be used.
Intervention code [1] 291122 0
Treatment: Drugs
Comparator / control treatment
no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294237 0
PK analysis with blood samples
Timepoint [1] 294237 0
PK analysis over 30 hours:
blood draws at T= 0, 15 min for 3 hours, every hour through hour 16 then every 2 hours through hour 30.
Primary outcome [2] 294238 0
Safety assessment with standard Adverse event evaluation and visual skin irritation and tolerability assessments at T0, T1, T6, T7, T12 T13 and T24 and T30 hours.
Timepoint [2] 294238 0
Safety assessments at T0, 1, 6, 7, 12, 13, 24 and 30 hours by verbal and visual assessments
Secondary outcome [1] 312861 0
Skin irritation from device/drug placement and drug delivery. Skin irritation is evaluated with a 7 point visual scale.
Timepoint [1] 312861 0
Over T=0, 1, 6, 7, 12, 13, 24 and 30 hours, the evaluation will be conducted.

Eligibility
Key inclusion criteria
smokers
caucasians
male
Minimum age
18 Years
Maximum age
50 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
infections
opiate use
consume more than 2 alcoholic beverages a day
skin tattoos

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)
Screening visit
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
descriptive statistics

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)
VIC
Recruitment postcode(s) [1] 9192 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 290702 0
Commercial sector/Industry
Name [1] 290702 0
Chrono Therapeutics Australia PTY LTD
Address [1] 290702 0
C/-MPR Group PTY LTD
Floor 19, HWT Tower
40 City Road
Southbank
Victoria 3004
Country [1] 290702 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Chrono Therapeutics Australia PTY LTD
Address
C/-MPR Group PTY LTD
Floor 19, HWT Tower
40 City Road
Southbank
Victoria 3004
Country
Australia
Secondary sponsor category [1] 289394 0
Commercial sector/Industry
Name [1] 289394 0
Nucleus Network Limited (Trading as Centre for Clinical Studies)
Address [1] 289394 0
5th Floor Burnet Tower, 89 Commercial Road, Melbourne
Victoria 3004
Country [1] 289394 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292337 0
The Alfred Ethics Committee
Ethics committee address [1] 292337 0
Commercial Road
Melbourne, Victoria 3004
Ethics committee country [1] 292337 0
Australia
Date submitted for ethics approval [1] 292337 0
22/01/2015
Approval date [1] 292337 0
03/02/2015
Ethics approval number [1] 292337 0
12/15

Summary
Brief summary
Phase 1 PK study with Descriptive statistics for Chrono Nicotine Replacement Therapy System (IDC-5)
Including assessment of general safety
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 54738 0
Dr Michael Araco
Address 54738 0
Nucleus Network
5th Floor Burnet Tower
89 Commercial Road
Melbourne Victoria 3004
Country 54738 0
Australia
Phone 54738 0
+61 (3) 9076 8900
Fax 54738 0
+61 3 9076 8911
Email 54738 0
M.Araco@nucleusnetwork.com.au
Contact person for public queries
Name 54739 0
Mr Cameron Johnson
Address 54739 0
Nucleus Network
5th Floor Burnet Tower
89 Commercial Road
Melbourne Victoria 3004
Country 54739 0
Australia
Phone 54739 0
+61 3 9076 8900
Fax 54739 0
+61 3 9076 8911
Email 54739 0
C.Johnson@nucleusnetwork.com.au
Contact person for scientific queries
Name 54740 0
Ms Patti Oto
Address 54740 0
Chrono Therapeutics Australia PTY LTD
3953 Eden Way
Hayward CA 94545, USA
Country 54740 0
United States of America
Phone 54740 0
+1-925-286-6991
Fax 54740 0
none
Email 54740 0
poto@chronothera.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary