Relative bioavailability of HTL0018318 oral formulations, v1
Research type
Research Study
Full title
A phase 1, randomised, open label, 2-period crossover, single centre, 3-arm, single dose study to investigate the relative bioavailability of HTL0018318 oral aqueous solution versus capsule formulation in healthy volunteers (16-024)
IRAS ID
214313
Contact name
Adeep Puri
Contact email
Sponsor organisation
Heptares Therapeutics Ltd
Eudract number
2016-003313-99
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
HTL0018318 is an experimental new medicine to treat ‘cognitive problems’, such as difficulty with understanding, reasoning, attention and memory. Those problems can occur in many brain disorders, including Alzheimer’s disease. We don’t know exactly what causes those symptoms, but they are linked to chemical imbalances in the brain. We hope that HTL0018318 will correct those imbalances by increasing the activation of a system that works in the brain through a substance called acetylcholine. We also hope that HTL0018318 is more effective and has fewer side effects than currently available medicines. \n\nIn this study, we’ll ask up to 36 healthy men and women, aged 18–55, to take 2 single doses of 5–20 mg of HTL0018318, by mouth, either as liquid or capsules. On 1 occasion, they’ll take HTL0018318 as liquid; on the other occasion, they’ll take it as capsules. We’ll compare blood and urine levels of the liquid and capsule forms of HTL0018318, and find out its side effects and effects on other body functions, such as breathing ability. We may also test the breakdown products of HTL0018318 and study how genes (pieces of DNA) affect the way the body responds to or handles medicines. \n\nParticipants will take up to 10 weeks to finish the study. They’ll make 4 outpatient visits and have 2 study sessions. They’ll stay on the ward for 8 nights in total (4 nights in each session. \n\nA pharmaceutical company, Heptares Therapeutics Ltd, is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
16/NI/0184
Date of REC Opinion
20 Sep 2016
REC opinion
Favourable Opinion