None listed
Conditions
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)
Interventions
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 exi
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.
Sponsors
Chrono Therapeutics Australia Pty LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed