Measurement of HTL0016878 in CS fluid in healthy male subjects
Research type
Research Study
Full title
A Phase 1, Open-Label, Randomised, Single-Centre, Single Oral Dose Study (10 mg and 20 mg) to Determine the Concentration of HTL0016878 in Cerebrospinal Fluid and Plasma in Healthy Male Subjects Following Dosing with HTL0016878 Oral Solution
IRAS ID
250390
Contact name
Claire Hirst
Contact email
Sponsor organisation
Heptares Therapeutics Ltd
Eudract number
2018-002784-26
Duration of Study in the UK
0 years, 1 months, 26 days
Research summary
The purpose of this study is to test HTL0016878 (the ‘study drug’) that is being developed for the treatment of certain psychiatric symptoms of Alzheimer’s Disease (depression, agitation and aggression) in healthy males. It also aims to help symptoms of schizophrenia (abnormal behaviour, false beliefs, failure to understand reality and disorganised speech).\n\nIn the body, chemicals called neurotransmitters are responsible for sending signals between nerves, around the body and in the brain. Dopamine is a neurotransmitter that is considered to play an important role in psychiatric symptoms seen in people suffering with Alzheimer’s Disease or schizophrenia. Current medication to treat these symptoms target dopamine receptors (proteins that dopamine binds to) in order to reduce the effects of dopamine. However, many of these medications also attach to other receptors which can cause side effects such as weight gain or heart and blood vessel problems. The study drug acts on a different type of receptor, which affects dopamine levels, but is not anticipated to bind to other receptors and therefore it is believed to produce minimal side effects when compared to existing treatments and help to improve the treatment for these conditions. \n\nThe main aims are:\n\nTo see how much of the study drug (orally given) enters the cerebrospinal fluid (fluid that surrounds and cushions the brain /spinal cord) by a procedure called Lumbar Puncture, where a need is inserted into the back of spine to collect the fluid.\n\nTo assess the safety and tolerability of the study drug, how the body absorbs and removes the study drug, what the study drug is broken down into, and how the body processes and removes the breakdown products.\n\nThis is a single-site study and will be conducted in the early phase unit of MAC Clinical Research. This study will last approximately 6 weeks with 3 study visits.
REC name
Wales REC 1
REC reference
18/WA/0290
Date of REC Opinion
13 Sep 2018
REC opinion
Further Information Favourable Opinion