A BA study investigating food effect on new formulation of cytisine
Research type
Research Study
Full title
A Phase 1 Open Label, Randomized, Two-Way Crossover Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation
IRAS ID
244924
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
Achieve Life Sciences Inc
Eudract number
2018-000786-37
Duration of Study in the UK
0 years, 5 months, 24 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.
A previous food effect study has been conducted in non-smokers using the original marketed formulation of cytisine (Tabex®) with results showing that there was no observable food effect in this formulation (Study ACH-CYT-01; REC Reference: 17/WA/0159).
However, the formulation for this product has been revised to eliminate lactose (an excipient) and introduce excipients which contain less formic acid which slows the formation of the breakdown substance N formylcytisine. There have been no changes to the active product (cytisine) and initial studies indicate that the revised formulation has improved stability at 24 months and potential for an extended shelf life at 36 months. As such, another food effect study is required in order to investigate the effect of food on the bioavailability of this new formulation i.e. how the body deals with the drug in the presence/absence of food. The study population has also been altered to use healthy smokers as opposed to non-smokers.
This study will be carried out in 12 subjects, approximately 6 males and 6 females (all smokers). All subjects will take part in two treatment periods over a period of 5 days. On both occasions, cytisine will be given (as 2 x 1.5 mg tablets), the only difference will be as to whether the drug is administered following an overnight fast or following a high fat breakfast.
Blood and urine samples will be collected at defined time-points in order to measure the drug concentration in the blood and urine.REC name
Wales REC 1
REC reference
18/WA/0112
Date of REC Opinion
5 Apr 2018
REC opinion
Favourable Opinion