HTL0016878 capsules vs oral solution (HMR 18-018)
Research type
Research Study
Full title
A phase 1, randomised, open-label, 3-period crossover, single dose study in healthy subjects, to assess the relative bioavailability of HTL0016878 from an oral capsule of HTL0016878 citrate salt versus an oral solution of HTL0016878 hydrochloride salt, and to assess the effect of food on the pharmacokinetics of HTL0016878 from the capsule (HMR Code: 18-018)
IRAS ID
1003711
Contact name
Temitope Adeloye
Contact email
Sponsor organisation
Heptares Therapeutics Limited
Eudract number
2018-003685-14
Research summary
Summary of Research
HTL0016878 (the study medicine) is an experimental new medicine for treating the symptoms of illnesses that affect the brain, such as Alzheimer’s disease and Schizophrenia. These illnesses can affect the way people think, feel or behave. Often, people with those diseases believe or see things that aren’t real, and experience extreme changes in mood, such as feeling more aggressive or anxious. We’re not sure what causes those symptoms, but they’ve been linked to chemical imbalances in the brain. We think that the study medicine will affect sites in the brain called M4 muscarinic receptors (M4 mAChRs) to help regulate levels of dopamine, and possibly other substances such as glutamate, which are some of the substances that can be imbalanced. We hope the study medicine will improve symptoms in people with illnesses that affect the brain at least as well as existing medicines, but with fewer side-effects.
We’re doing this study to compare the blood levels and safety of two forms of study medicine: an existing liquid form and a new capsule form. We’ll also test whether food affects blood levels of the study medicine when it is taken as the new capsule form.
We’ll give 15 healthy volunteers, aged 18 to 50, a single dose of the study medicine in 3 study sessions. In each session, they’ll take a single dose as either a liquid after an overnight fast, as capsules after an overnight fast, or as capsules after a high-fat breakfast.
Participants will take up to 5 weeks to finish the study. They’ll have 3 study sessions and stay on the ward 5 days and 4 nights in a row in each session. They’ll have 1 outpatient visit.
A pharmaceutical company (Heptares Therapeutics Ltd) is funding the study.
The study will take place at 1 centre in London.
Summary of results
This was a Phase 1 trial in healthy volunteers with no therapeutic intent. For reasons of commercial confidentiality a lay summary of the trial results is not provided. The sponsor would like to thank the participants for being part of the trial and the trial is now complete.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0075
Date of REC Opinion
18 Jun 2021
REC opinion
Further Information Favourable Opinion