Safety, tolerability & PK of LML134 as SAD in healthy Subjects
Research type
Research Study
Full title
A first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending oral dose study, to assess the safety, tolerability and pharmacokinetics of LML134 in healthy volunteers
IRAS ID
164444
Contact name
Annelize Koch
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2014-000937-22
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
The new medicine tested in this study is a compound called LML134. It is hoped that LML134 will be helpful in treating patients with excessive sleepiness, which is one of the major symptoms in sleep disorders. It also affects many patients with neurological disorders, like Parkinson’s disease, stroke and traumatic brain injury.
The study is divided into Part 1 (single ascending dose), Part 2 (multiple ascending dose), Part 3 (food effect) and Part 4( biomarkers in the cerebrospinal fluid). Separate groups of participants will be included in each part of the study. This application is only intended for subjects who will be included in Part 1, as this part of the study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Harrow, UK.
The main purpose of the study part 1 is to see how safe and how well tolerated LML134 is when given as single oral doses in healthy subjects. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at what effects the study drug will have in the body. The study will also try to understand why different people respond differently to the same drug through DNA testing.
This part of the study will recruit healthy, non smoking, males and females (of non-childbearing potential) between the ages of 18 and 55 years. Approximately 64 subjects will take part in this study. Additional subjects, up to a maximum of 16 subjects, may be enrolled in this part of the study should additional doses be needed or additional dose groups be added.
Vital signs, safety ECG measurements, safety EEG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic analysis will be collected
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/1863
Date of REC Opinion
31 Dec 2014
REC opinion
Further Information Favourable Opinion