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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001258347

Enrollment

Registered

2017-08-30

Start date

2017-10-18

Completion date

2017-10-26

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results