NCT03303911

A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers

Repeat-Dose Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Cytisine	film-coated tablets; depending on arm assignment, 1 or 2 tablets to be taken with 240 mL water for each dose

Timeline

• Start date: 2017-10-06
• Primary completion: 2018-10-05
• Completion: 2018-10-05
• First posted: 2017-10-06
• Last updated: 2019-10-21
• Results posted: 2019-10-21

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study