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Trial registered on ANZCTR


Registration number
ACTRN12617001258347
Ethics application status
Approved
Date submitted
22/08/2017
Date registered
30/08/2017
Date last updated
15/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single-Center, Open-Label Pharmacokinetic (PK) Study to Assess the PK Profile of Nicotine Delivered by the Chrono Quit Smoking Solution (CQSS2)
Scientific title
A Single-Center, Open-Label Pharmacokinetic (PK) Study in male smokers to Assess the PK Profile of Nicotine Delivered by the Chrono Quit Smoking Solution (CQSS2)
Secondary ID [1] 292703 0
PK2017-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cigarette addiction
304459 0
Condition category
Condition code
Mental Health 303798 303798 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Chrono Quit Smoking Solution (CQSS2) is a Nicotine Replacement Therapy System. The dosing period consists of one day with approximately 21 mg of nicotine delivered transdermally using the CQSS2. Doses of 5.4% nicotine formulation are delivered transdermally via the CQSS2 worn either on the upper arm or mid-thigh at programmed intervals of T0, T0.5, T1, T7, T7.5, T13 hours. Participants are required to stay in the clinic for the one day treatment and required to wear the CQSS2 for approximately 24 hours for a full PK parameters evaluation. The CQSS2 treatment will be administered by the health care provider. A strap (i.e., Comfort Band), will be the primary method used to attach the CQSS2 to the body.
Intervention code [1] 298943 0
Treatment: Drugs
Intervention code [2] 298964 0
Treatment: Devices
Comparator / control treatment
Participants will be randomly allocated to wear the CQSS2 on either the upper arm or the mid-thigh.
Control group
Active

Outcomes
Primary outcome [1] 303158 0
PK concentration profile of nicotine delivered by the Chrono Quit Smoking Solution (CQSS2) system
Timepoint [1] 303158 0
PK analysis over 30 hours:
blood samples will be collected approximately 15 mins prior to the first dose, every 20 minutes for the first 2 hours, at Hour 2.5, hourly from Hour 3 through Hour 16, then every 2 hours thereafter through Hour 30.
Secondary outcome [1] 338057 0
Safety of the Chrono Quit Smoking Solution (CQSS2) system
Vital signs will be monitored periodically throughout the active period of dosing for possible adverse events of: Bradycardia (resting pulse rate <40 beats per minute [bpm]); Tachycardia (resting pulse rate >120 bpm); Blood pressure <90 or >165 mmHg systolic; Blood pressure <45 or >105 mmHg diastolic.
Timepoint [1] 338057 0
Adverse events will be collected from the time of the application of the CQSS2 through the Follow-up visit (within 14 days of discharge).

Secondary outcome [2] 338221 0
Tolerability of the Chrono Quit Smoking Solution (CQSS2) system
Skin irritation at the CQSS2 application site will be assessed on an 8-point Skin Irritation Assessment scale
Timepoint [2] 338221 0
Skin irritation at the CQSS2 application site will be assessed on an 8-point Skin Irritation Assessment scale (0 to 7) up to 30 minutes prior to placement of the system, immediately after removal of the system at the 30 hour time point, and at the Follow-up visit. Any score more than or equal to 3 will be reported as an AE and documented with photographic evidence. All application site AEs will be followed until the event is resolved, returns to baseline, or the Follow-up visit (within 14 days of discharge), whichever occurs first.

Eligibility
Key inclusion criteria
Smokers consuming on average more than or equal to 10 cigarettes per day for at least the past 6 months, confirmed by self report
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
infections
opiate use
males who consume more than 4 alcoholic beverages per day for the past month
tattoos that could interfere with skin assessments

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)
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
Pharmacokinetic endpoints will be evaluated and summarized descriptively.

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 hospital [1] 8843 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 16978 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 297342 0
Commercial sector/Industry
Name [1] 297342 0
Chrono Therapeutics Australia PTY LTD
Address [1] 297342 0
C/-MPR Group PTY LTD
Floor 19, HWT Tower
40 City Road
Southbank
Victoria 3004
Country [1] 297342 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] 296319 0
Commercial sector/Industry
Name [1] 296319 0
Nucleus Network Limited (Trading as Centre for Clinical Studies)
Address [1] 296319 0
5th Floor Burnet Tower, 89 Commercial Road, Melbourne
Victoria 3004
Country [1] 296319 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298442 0
The Alfred Ethics Committee
Ethics committee address [1] 298442 0
Commercial Road
Melbourne, Victoria 3004
Ethics committee country [1] 298442 0
Australia
Date submitted for ethics approval [1] 298442 0
30/08/2017
Approval date [1] 298442 0
27/09/2017
Ethics approval number [1] 298442 0
442/17

Summary
Brief summary
This study is a Phase 2, open-label, PK study to assess the PK profile of nicotine over a 30 hour period in healthy Caucasian male volunteers who are smokers, using the Chrono Quit Smoking Solution (CQSS2) system. All subjects will receive the CQSS2.
A strap (i.e., Comfort Band) will be the primary method used to attach the CQSS2 to the body. Subjects will be randomized in a 1:1 ratio to wear the CQSS2 in one of two application site locations, the upper arm (n = 5) or mid thigh (n = 5), for approximately 30 hours. Application site location, safety, and tolerability will be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77106 0
Dr Jason Lickliter
Address 77106 0
Nucleus Network 5th Floor Burnet Tower 89 Commercial Road Melbourne
Victoria 3004
Country 77106 0
Australia
Phone 77106 0
+61 3 9076 8960
Fax 77106 0
+61 (3) 9076 8900
Email 77106 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 77107 0
Mr Cameron Johnson
Address 77107 0
Nucleus Network 5th Floor Burnet Tower 89 Commercial Road Melbourne
Victoria 3004
Country 77107 0
Australia
Phone 77107 0
+61 3 9076 8906
Fax 77107 0
+61 (3) 9076 8900
Email 77107 0
c.johnson@nucleusnetwork.com.au
Contact person for scientific queries
Name 77108 0
Mrs Patricia Oto
Address 77108 0
Chrono Therapeutics Australia PTY LTD
3953 Point Eden Way,
Hayward, CA 94545
Country 77108 0
United States of America
Phone 77108 0
+1-925-286-6992
Fax 77108 0
None
Email 77108 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