drugset / Trial / NCT03303911

A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers

NCT03303911

Phase 1/2 Terminated 26 enrolled Achieve Life Sciences
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytisinicline Small molecule 1.5 mg
Subject Cytisinicline Small molecule 3 mg

Indications

No indication recorded.