PK, Tolerability of CNV1014802 in healthy young & elderly subjects
Research type
Research Study
Full title
A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of an oral dose regimen of 150mg tid CNV1014802 in healthy young versus elderly male and female subjects
IRAS ID
167194
Contact name
Annelize Koch
Contact email
Sponsor organisation
Convergence Pharmaceuticals Ltd
Eudract number
2014-004980-19
Duration of Study in the UK
0 years, 2 months, 12 days
Research summary
The new medicine tested in this study is a compound called CNV1014802. It is hoped that the study drug will be useful as a treatment for chronic pain conditions such as a type of recurring pain attacks in the face known as trigeminal neuralgia. The pain itself can be severe and distressing. If left untreated, this may cause depression and anxiety.
The main purpose of the study is to see how age and gender may effect how the study drug is taken up, broken down, distributed through the body and excreted. To determine how safe the study drug is and how well it is tolerated between young and elderly subjects. The study will also Investigate if the drug has effects on wakefulness, reaction times and on the ability to think (cognition).
This study will recruit healthy young males and females between the ages of 18 to 45 years (inclusive) and healthy elderly males and females over the age of 65 years . A total of 32 subjects will take part in the study.
Vital signs, safety ECG measurements, safety laboratory assessments, safety neuropsychological assessments and questionnaires, neurological and physical examination, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood and urine samples for pharmacokinetic analysis will be collected.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/1234
Date of REC Opinion
2 Feb 2015
REC opinion
Further Information Favourable Opinion