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Trial registered on ANZCTR


Registration number
ACTRN12615001287527
Ethics application status
Approved
Date submitted
19/11/2015
Date registered
26/11/2015
Date last updated
11/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A PHASE I , Randomized, Double-Blind, Placebo-Controlled Pharmacokinetic Study of the Chrono Nicotine Replacement Therapy System
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Pharmacokinetic Study of the Chrono Nicotine Replacement Therapy System for adult male smokers
Secondary ID [1] 287946 0
PK2015-002
Universal Trial Number (UTN)
U1111-1176-7190
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation 296826 0
Condition category
Condition code
Mental Health 297053 297053 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To characterize the pharmacokinetic (PK) concentration profile of nicotine delivered by the drug delivery system / device. This study will use a wearable drug delivery prototype device that is strapped to the arm. The device delivers nicotine transdermally to achieve repeated peaks and troughs throughout the day. By tailoring these doses to pre-empt the regular craving and peak smoking episodes that smokers experience during the day; the product may significantly increase the efficacy of existing nicotine replacement therapy (NRT) products.
The nicotine formulation - 6% weight per volume (w/v) concentration in a 50/50 volume per volume (v/v) ethanol/water (EtOH/H20) mixture. A bolus of 125 microliters of nicotine or placebo will be delivered to the subjects via the device at Time = 0, 0.5, 1, 7, 7.5, and 13 hours. The solutions are immediately absorbed onto Transdermal Membrane of the devices. Subject are confined for 30 hours and followed up for 7 days post treatment.
Intervention code [1] 293291 0
Treatment: Devices
Intervention code [2] 293299 0
Treatment: Drugs
Comparator / control treatment
The placebo formulation - a 50/50 volume per volume (v/v) ethanol/water (EtOH/H20) mixture only
Control group
Placebo

Outcomes
Primary outcome [1] 296656 0
To characterize the pharmacokinetic (PK) concentration profile of nicotine delivered by the drug delivery system.

Pharmacokinetic Analysis: Pharmacokinetic endpoints (e.g., Tmax, Cmax, AUCs, t1/2) will be evaluated and summarized using descriptive statistics. Nicotine concentrations also will be summarized with descriptive statistics.
Timepoint [1] 296656 0
Pharmacokinetic (PK) sampling: blood samples will be collected prior to the first dose, every 30 minutes for the first 3 hours, hourly thereafter through Hour 16, then every 2 hours through Hour 30
Secondary outcome [1] 319019 0
Assess safety, tolerability of the drug delivery system / device
Timepoint [1] 319019 0
Adverse event (AE) assessment and vital signs (including temperature, pulse, respiratory rate, and systolic/diastolic blood pressure) will be monitored and collected prior to the first dose, every 30 minutes for the first 3 hours, hourly thereafter through Hour 16, then every 2 hours by the Investigator or designed staff for the 30 hours of confinement and at the Day 7 Follow-up visit.

Clinical safety labs (chemistry and hematology) will be assessed at screening, admission and follow-up. Laboratory values that are out of range will be identified and may be repeated at the Investigator’s discretion.
Secondary outcome [2] 319058 0
Assess nicotine craving post administration of nicotine formulation verses placebo formulation by the device
Timepoint [2] 319058 0
The Fagerstrom Test for Nicotine Dependence (FTND) will be completed prior to study drug dosing on Day 1.

Cravings assessment: The 10-item Question of Smoking Urges (QSU) will be completed prior to study drug dosing on Day 1. A single question cravings assessment will be performed at 5 minutes (+/- 1 minute) after every 2 hours through Hour 22.

The QSU will be repeated at hour 14.

The Mood and physical symptoms scale (MPSS) assessment will be completed at hour 24 to obtain a retrospective assessment of their cravings

Eligibility
Key inclusion criteria
1. Caucasian males, aged 18–50 years, inclusive.
2. Smokers consuming on average between 20 and 40 cigarettes per day
3. Body mass index (BMI) between 18.50 and 29.99 kg/m2.
4. Ability to understand study procedures and provide written informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects with screening clinical laboratory tests, physical examination (PE), or electrocardiogram (ECG) outside normal range
2. Subjects who have known or suspected infection with tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
3. Subjects with positive screening urine test for non-prescription drugs, including opiates, amphetamines, barbiturates, benzodiazepines, methadone, cocaine and its metabolites, or cannabinoids.
4. Subjects who are mentally or legally incapacitated, or have a history of psychiatric disorder.
5. Subjects with severe hepatic, renal, cardiovascular, endocrine, or hematologic diseases, or with a history or illness
6. Subjects with any sign of infection, with dermatologic diseases, or any condition that would inhibit transdermal absorption.
7. Subjects who consume more than two alcoholic beverages per day on average
8. Subjects who require any medications that may interfere with the absorption, metabolism, or excretion of the study drug.
9. Subjects that have 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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Analysis Methods for the Primary and Secondary Endpoints and Testing Procedures:
Plasma concentrations of nicotine will be quantitated after administration of multiple doses via the device.
No power calculations were performed for this study. All comparisons will be considered exploratory and hypothesis generating.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/09/2015
Date of last participant enrolment
Anticipated
Actual
24/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12268 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 292427 0
Commercial sector/Industry
Name [1] 292427 0
Chrono Therapeutics Australia Pty LTD
Country [1] 292427 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, VIC 3006
Country
Australia
Secondary sponsor category [1] 291116 0
None
Name [1] 291116 0
Address [1] 291116 0
Country [1] 291116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293887 0
Alfred Health (ABN 27 318 956 319)
Ethics committee address [1] 293887 0
Ethics committee country [1] 293887 0
Australia
Date submitted for ethics approval [1] 293887 0
10/08/2015
Approval date [1] 293887 0
07/09/2015
Ethics approval number [1] 293887 0
388/15

Summary
Brief summary
This study is a Phase I, randomized, double-blind, placebo-controlled PK study of nicotine levels over a 30 hour period in healthy Caucasian male volunteers, 12 per arm (blinded), who are smokers, using the Chrono Nicotine Replacement Therapy System.
Study participation will involve:
*Screening: 1 site visit (up to 14 days prior to Day 1)
* Study Treatment: 30 hours in an in-patient facility
* Follow-up: 1 site visit (within 7 to 10 days of discharge)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61694 0
Dr Jason Lickliter
Address 61694 0
Nucleus Network Pty LTD
The Burnet Tower, 5th Floor
89 Commercial Road
Melbourne, VIC 3004
Country 61694 0
Australia
Phone 61694 0
+61 407 527 307
Fax 61694 0
+61 3 9076 8911
Email 61694 0
[email protected]
Contact person for public queries
Name 61695 0
Ms Elizabeth Glatz
Address 61695 0
Nucleus Network Pty LTD
The Burnet Tower, 5th Floor
89 Commercial Road
Melbourne, VIC 3004
Country 61695 0
Australia
Phone 61695 0
+61 3 9076 8921
Fax 61695 0
+61 3 9076 8911
Email 61695 0
[email protected]
Contact person for scientific queries
Name 61696 0
Ms Patricia Oto
Address 61696 0
Chrono Therapeutics
3953 Point Eden Way
Hayward, California
94545 USA
Country 61696 0
United States of America
Phone 61696 0
+1 (510) 362-7788
Fax 61696 0
+1 (510) 362-7787
Email 61696 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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