Relative bioavailability study of DNL201 Formulations (QSC202105)
Research type
Research Study
Full title
A Two-Part, Open-Label, Pharmacokinetic Study to Evaluate the Relative Bioavailability of DNL201 Formulations in Healthy Subjects
IRAS ID
262488
Contact name
Angela Kay
Contact email
Sponsor organisation
Denali Therapeutics Inc.
Eudract number
2019-000967-25
Duration of Study in the UK
0 years, 7 months, 5 days
Research summary
The sponsor is developing a new test medicine called DNL201 as a potential treatment of Parkinson’s disease.\n\nParkinson’s disease is a condition where parts of the brain become progressively damaged over many years. The disease causes 3 main symptoms; involuntary shaking of particular parts of the body (tremor), slow movement, and stiff and inflexible muscles. It may also cause a wide range of other physical and psychological symptoms such as depression and anxiety, issues with balance, a loss of sense of smell and problems with sleeping. \n\nThis study will try to identify if there is a difference in the amount of the test medicine absorbed by the body when using different formulations (recipes) of DNL201. Safety and tolerability of the test medicine will also be investigated.\n\nThe study will consist of up to 2 parts. In Part 1, 16 healthy male and female volunteers will attend the clinical unit on up to 5 occasions (periods) to receive single oral doses of DNL201, in the form of a DNL201 capsule reference and multiple DNL201 prototype capsule formulations (recipes). In Part 2 (optional), 16 healthy male and female volunteers will attend the clinical unit on 5 occasions (periods) to receive single oral doses of DNL201, in the form of a DNL201 capsule reference and multiple DNL201 tablet formulations. In both parts, there will be a washout period of at least 5 days between each dose.\n\nIn both Parts, volunteers will remain in the clinic until Day 3 of each period then attend a return visit on Day 4 for a PK blood sample. Volunteers will receive a follow-up phone call 7 to 10 days after their final dose to ensure their continued wellbeing.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0173
Date of REC Opinion
3 Jun 2019
REC opinion
Further Information Favourable Opinion