A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers

Summary

The primary objectives of this study are: * To evaluate the pharmacokinetic (PK) parameters during repeat dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule. * To evaluate the pharmacodynamic (PD) effects (e.g., reduction in smoking) with repeat dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule.

Timeline

Start

2017-10-06

Primary completion

2018-10-05

Completion

2018-10-05

Outcome

Outcome not reported

Stopped (Enrollment): “It has been difficult to recruit participants meeting study entry criteria that are \>65 years of age and not for any safety reasons.”

Drugs

Indications

No indication recorded.