A PK study in single and multiple oral doses of NRM8499
Research type
Research Study
Full title
A Phase 1, Single-Centre, Double-Blind, Randomised, Placebo-Controlled Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of NRM8499 Administered as Single and Multiple Oral Doses to Healthy Young Males and Healthy Elderly Male and Female Subjects
IRAS ID
46952
Contact name
darren wilbraham
Sponsor organisation
BELLUS Healthcare
Eudract number
2009-018159-18
Research summary
NRM8499 is being developed for the treatment of Alzheimer's disease and is related to the drug tramiprosate. Patient studies with tramiprosate did not show a statistically significant benefit in symptoms associated with Alzheimer's disease and the clinical development of tramiprosate was halted. NRM8499 is a pro-drug of tramiprosate and it is hoped that NRM8499 will allow higher concentrations of tramiprosate to be available in the body and thus improve the symptoms for patients with Alzheimer's disease. This study will examine the safety, tolerability and the way the body handles single doses of tramiprosate and NRM8499, and multiple oral doses of NRM8499 in healthy young and elderly volunteers. The study will be conducted at Quintiles Drug Research Unit at Guy's Hospital. This study will be divided into four parts. Part A: To compare a single dose of NRM8499 to tramiprosate. Eight (8) young healthy male subjects aged between 18 and 45 years and 8 healthy elderly male and female subjects aged 50 years and over. Part B: To investigate single rising doses of NRM8499. Thirty-two (32) healthy elderly male and female subjects aged 50 years and over (up to 4 groups with 8 subjects in each group). Part C: To investigate the effect of food on single doses of NRM8499. Twelve (12) healthy elderly male and female subjects aged 50 years and over. Part D: To investigate multiple rising doses of NRM8499. Twenty-four (24) healthy elderly male and female subjects aged 50 years and over (up to 3 groups with 8 subjects in each group).
REC name
London - London Bridge Research Ethics Committee
REC reference
10/H0804/10
Date of REC Opinion
5 Mar 2010
REC opinion
Favourable Opinion