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