Effect of LML134 on brain H3 receptor occupancy in healthy volunteers
Research type
Research Study
Full title
An open-label, adaptive design study in healthy volunteers to characterize regional brain H3 receptor occupancy following single dose of the H3 receptor inverse agonist LML134 by using positron emission tomography (PET) with the radioligand [11C]MK-8278
IRAS ID
205461
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Novartis Institutes of BioMedical Research
Eudract number
2015-002236-40
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
The new medicine tested in this study is a compound called LML134, which is being developed for the treatment of excessive sleepiness, one of the major symptoms in sleep disorders. Excessive sleepiness can cause suffering for affected patients, interfere with daily activities and could increase the risk of accidents.
The main purpose of the study is to look at how LML134 binds to receptors in the brain and at which dose level this binding is optimal. A further aim of the study is to see how safe the study medicine is and how well it is tolerated after dosing.
Each participant will be given a single oral dose of the study medicine. They will also receive a radioactive tracer and undergo imaging assessments to visualize the binding of the LML134 to the brain receptors.
The study will be conducted at one site in the United Kingdom. A total of 6 healthy volunteers will be enrolled in the study for three cohorts (2 subjects in each cohort) and receive one single dose of the study medication. The study will recruit healthy male participants between the ages of 25 and 55 years. Based on the results of the 3 cohorts, 2 additional cohorts of a maximum of 4 subjects (2 subjects per cohort), could be included to complete the primary study objective.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/0721
Date of REC Opinion
4 Jul 2016
REC opinion
Further Information Favourable Opinion