NCT03268343

A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine

A Phase 1 Open Label, Randomized, Two-Way Crossover Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be an open-label, randomised, 2-period, single-dose crossover study to determine the comparative bioavailability of cytisine following single-dose administration in healthy male and female subjects under fed and fasted conditions. The study will be comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Cytisine	Cytisine 1.5 mg Film-Coated Tablets

Timeline

• Start date: 2017-08-08
• Primary completion: 2017-08-26
• Completion: 2017-09-01
• First posted: 2017-08-31
• Last updated: 2019-02-26
• Results posted: 2019-02-07

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study