Study to assess PK of HTL0009936 in 5 oral MR formulations (QCL117192)
Research type
Research Study
Full title
A Phase I Relative Bioavailability Study in Healthy CYP2D6 Intermediate and Extensive Metaboliser Subjects, Designed to Evaluate the Pharmacokinetic Profile of HTL0009936 Following Single Dose Administration of Modified Release Prototype Formulations
IRAS ID
193321
Contact name
Jan Liptrot
Contact email
Sponsor organisation
Heptares Therapeutics Limited
Eudract number
2015-004921-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 22 days
Research summary
The Sponsor is developing the study drug, HTL0009936, for the potential treatment of Alzheimer’s disease. Alzheimer’s disease is the most frequent form of dementia in the elderly and causes degeneration in brain systems involved in memory, thought and emotion. Incidence of dementia increases with age, effecting almost 50% of 85 year olds, and climbing dramatically in those over 90 years of age. \n\nCurrently HTL0009936 is given as a liquid three times daily or as an intravenous infusion. The Sponsor would like to develop a tablet that only needs to be taken twice daily. The study will therefore try to identify how the body takes up the study drug HTL0009936 when it is dosed as different tablet formulations compared to the current liquid formulation. The best formulation will be tested in the fed and fasted state. By comparing how well the body takes up the new formulations we may be able to identify the best formulation.\n \nThe study will consist of 6 sequential treatment regimens (A-F) involving up to 14 healthy male and non-pregnant, non-lactating female subjects. They will each receive single doses of the different formulations of the study drug in sequence. There will be sufficient time between each dosing occasion to allow the study drug to have been eliminated from the body prior to the next dose. In regimen A, volunteers will receive a new modified release (MR) formulation after an overnight fast. In regimen B, volunteers will receive the reference immediate release formulation after an overnight fast. In regimens C-F volunteers will receive a new MR formulation either after food or in a fasted state. The principle investigator and sponsor will review safety data from each treatment regimen prior to giving a higher dose to ensure the safety of the volunteers.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0454
Date of REC Opinion
5 Feb 2016
REC opinion
Further Information Favourable Opinion