Repeat-Dose PK and PD Evaluation of Cytisine in Healthy Smokers
Research type
Research Study
Full title
Repeat-Dose Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers
IRAS ID
233817
Contact name
Annelize Koch
Contact email
Sponsor organisation
Achieve Life Sciences Inc
Eudract number
2017-003257-42
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
This study will be looking at cytisine (Tabex®) to know how the body absorbs and gets rid of the drug and the drug benefits (e.g reduction in smoking) when administered to subjects at either 1.5 mg or 3.0 mg dose levels for 25 days using the commercial administrative schedule for the marketed product.
This study will be carried out in 36 subjects of which 24 subjects are between 18-65 years and 12 subjects are above 65 years. Approximately 18 males and 18 females. All subjects will take part in treatment schedule from day 1 to day 25 and they may receive either 1.5mg or 3.0mg of cytisine.
Cytisine (Tabex®) has been marketed in central and eastern Europe by Sopharma PLC. Although cytisine is administered as a standard 25-day treatment at 1.5 mg dose, there has not been any formal study conducted to evaluate detailed pharmacokinetics for repeated doses at 1.5 mg or 3.0 mg in adult smokers. This study will also assess general safety and efficacy assessments for both the 1.5mg and the 3.0 mg dose.
REC name
Wales REC 2
REC reference
17/WA/0275
Date of REC Opinion
16 Sep 2017
REC opinion
Favourable Opinion