A study to investigate the effects of food and formulation on DNL151
Research type
Research Study
Full title
AN OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO ASSESS THE EFFECTS OF FORMULATION AND FOOD ON THE BIOAVAILABILITY OF DNL151 IN HEALTHY SUBJECTS
IRAS ID
271424
Contact name
Annelize Koch
Contact email
Sponsor organisation
Denali Therapeutics Inc.
Eudract number
2019-003180-22
Duration of Study in the UK
0 years, 2 months, 21 days
Research summary
This study is a single dose, 3 period study with randomized treatment in the first 2 study periods and a fixed treatment in period 3. In this study, participants will receive a single dose of the study drug on 3 occasions (separated by 14 days).\n\nThe purpose of this study is to investigate the study drug DNL151. The study will look at how giving the study drug in different forms i.e. as a tablet or a powder in capsule affects how the drug acts in the body. Additionally the study may assess if taking the study drug with food or at a different dose has any effect on how the drug acts in the body. \n\nThese factors will be assessed by taking blood samples and measuring how the levels of the drug change in the blood over a period of time after dosing.\n\nThe study sponsor is developing this drug for the treatment of Parkinson’s Disease which is a long-term progressive disorder of the nervous system.\n\nThe study will be conducted in 24 healthy volunteers (males and females of non-child bearing potential).\n
REC name
Wales REC 1
REC reference
19/WA/0240
Date of REC Opinion
6 Sep 2019
REC opinion
Favourable Opinion