A food effect BA study looking at Cytisine in healthy volunteers
Research type
Research Study
Full title
A Phase 1 Open Label, Randomized, Two-Way Crossover Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine
IRAS ID
228527
Contact name
Annelize Koch
Contact email
Sponsor organisation
Achieve Life Sciences Inc
Eudract number
2017-001562-19
Duration of Study in the UK
0 years, 4 months, 21 days
Research summary
This study will be looking at Cytisine (Tabex®) when administered to subjects who have been given a high fat breakfast, or have not eaten and have fasted overnight.
Tabex® has been licensed and marketed in central and eastern Europe for several decades by Sopharma PLC. Despite this, it remains relatively unknown in other parts of the world.
This study will be carried out in 24 subjects. Approximately 12 males and 12 females. All subjects will take part in two treatment periods. On both occasions Cytisine will be given, the only difference is whether its administered after a high fat breakfast or after an overnight fast.
A fed/fasted study of Cytisine has not been conducted and the idea of this study is to see what effect food has on the way someone’s body handles the drug. Blood samples will be taken at selected timepoints in order to assess this.
REC name
Wales REC 2
REC reference
17/WA/0159
Date of REC Opinion
22 Jun 2017
REC opinion
Favourable Opinion