Evaluation of Bioavailability of ALZ-801 Formulations (117350)
Research type
Research Study
Full title
A Four-Period, Single-Dose, Sequential Study in Healthy Males and Females of Non-Childbearing Potential, Designed to Assess the Pharmacokinetics of ALZ-801 and Tramiprosate from ALZ-801 Prototype Tablet Formulations and to Assess the Effect of Food on the Bioavailability of ALZ-801 and Tramiprosate for a Selected Prototype Tablet
IRAS ID
182223
Contact name
Susan Ward
Contact email
Sponsor organisation
Alzheon Inc.
Eudract number
2015-002035-18
Duration of Study in the UK
0 years, 2 months, 17 days
Research summary
The Sponsor is developing the study drug, ALZ-801, for the potential treatment of Alzheimer’s disease. Alzheimer’s disease (AD) is an irreversible, progressive disorder leading to the loss of nerve function and structure, characterised by gradual decline in mental function, abnormal behaviour and personality changes.\n\nThe study will try to determine if changes in the formulation of the study drug will have a notable effect on the metabolism of the study drug and quantity of active ingredient available in the body.\n\nThe study will consist of 5 study periods, involving 12 healthy male and female subjects. Each subject will receive the following treatments:\n•\tRegimen A: ALZ-801 171 mg tablet (equivalent to 100 mg tramiprosate) in the fasted state\n•\tRegimen B: Tramiprosate 100 mg loose fill capsule (reference) in the fasted state\n•\tRegimen C: ALZ-801 X mg tablet (equivalent to X mg tramiprosate) in the fasted state\n•\tRegimen D: ALZ-801 X mg tablet (equivalent to X mg tramiprosate) in the fasted state (may also be dosed in the fed state depending on emerging data)\n•\tRegimen E: ALZ-801 X mg tablet (equivalent to X mg tramiprosate) in the fed state (may also be dosed in the fasted state depending on emerging data)\n\nThe alternative conditions will be variables in the concentration of active substance. There will be a minimum washout period of 7 days between study periods. The washout period between regimens, where an interim decision will be made will be 14 days, to allow for the decision process and manufacture of the selected formulation..\n
REC name
HSC REC B
REC reference
15/NI/0115
Date of REC Opinion
22 Jun 2015
REC opinion
Further Information Favourable Opinion