HTL0016878 – first doses in humans: version A
Research type
Research Study
Full title
A two-part, randomised, double-blind, placebo controlled single and multiple ascending dose study to assess safety, pharmacokinetics and pharmacodynamics of oral HTL0016878 in healthy younger adult and elderly subjects with a randomised, open-label, crossover arm to assess the effect of food on bioavailability of oral HTL0016878. (16-028)
IRAS ID
226981
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Heptares Therapeutics Ltd
Eudract number
2017-001385-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (HTL0016878) is an experimental treatment for symptoms of illnesses that affect the brain. We hope that HTL0016878 will change levels of dopamine in the brain, by activating specific sites called M4 muscarinic receptors (mAChRs), and improve symptoms of those illnesses. We hope that it’ll work better than existing medicines, and have fewer side effects. \n\nThis is a 2-part study (Part 1A–C and Part 2A–B) in healthy adults, aged 18–55, and 65 years and over. \n\nIn Part 1, we’ll give single doses of HTL0016878 to 5 groups of participants: Groups 1–3 (up to 30 healthy men); Group 4 (up to 6 healthy men and women); and Group 5 (up to 6 older men). \n\nHTL0016878 has never been given to humans before. The first dose will be 0.5 mg, and we plan to increase it as the study progresses. We aim to find out its side effects, blood levels, age and food effects.\n\nWe think HTL0016878 must reach the brain and spinal cord to be effective, so in 1 session in Group 4 we’ll take a 1 mL cerebrospinal fluid (CSF) sample from each participant, by lumbar puncture, and measure levels of HTL0016878. \n \nIn Part 2, we’ll test repeated doses of HTL0016878, in up to 8 groups of 8 participants each, to find out its side effects, blood levels and age effects. We plan to increase the dose as the study progresses.\n\nParticipants will take 7–17 weeks to finish the study. They’ll have 1–4 study sessions and stay on the ward for: up to 3 nights in each session (Part 1); or 9 nights (Part 2). They’ll make 3–6 outpatient visits.\n\nA pharmaceutical company (Heptares Therapeutics Ltd) is sponsoring the study.\nThe study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
17/NI/0106
Date of REC Opinion
25 Jul 2017
REC opinion
Further Information Favourable Opinion