A Single-Center, Open-Label Pharmacokinetic (PK) Study to Assess the PK Profile of Nicotine Delivered by the Chrono Quit Smoking Solution (CQSS2)
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)
Chrono Therapeutics Australia PTY LTD
10 participants
Oct 18, 2017
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Smokers consuming on average more than or equal to 10 cigarettes per day for at least the past 6 months, confirmed by self report
Exclusion Criteria4
- infections
- opiate use
- males who consume more than 4 alcoholic beverages per day for the past month
- tattoos that could interfere with skin assessments
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Interventions
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.
Locations(1)
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ACTRN12617001258347