A DDI study of Diltiazem and DNL151 in healthy volunteers
Research type
Research Study
Full title
A FIXED-SEQUENCE CROSSOVER, DRUG-DRUG INTERACTION STUDY EVALUATING THE EFFECT OF THE CYTOCHROME P450 3A INHIBITOR DILTIAZEM ON DNL151 IN HEALTHY SUBJECTS
IRAS ID
278116
Contact name
Annelize Koch
Contact email
Sponsor organisation
Denali Therapeutics Inc.
Eudract number
2020-000046-34
Duration of Study in the UK
0 years, 2 months, 10 days
Research summary
The purpose of this study is to investigate the study drug DNL151.\n\nThe study is classed as a drug-drug interaction study. Participants will be given a drug that has a known effect in the body (diltiazem) and then given the study drug (DNL151) to determine if there is any effect or interaction between the two drugs in the body and whether administration of diltiazem affects the safety and tolerability of DNL151. \n\nIn this study, all participants will receive the same treatment in the same order. In treatment period 1, participants will be given a single 50 mg dose of DNL151. In treatment period 2, participants will be given 240 mg of diltiazem once a day for a period of 14 days. After participants have taken diltiazem for 4 days, they will be given both diltiazem and DNL151 together on Day 5 (of treatment period 2 i.e. study Day 20).\n\nDuring both treatment periods, blood samples will be taken to measure the concentrations of DNL151 in the blood over a period of time. A comparison of concentrations between treatment period 1 and 2 will determine if diltiazem has any effect on the concentrations of DNL151 in the blood.\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 16 healthy volunteers (males and females of non-child bearing potential).
REC name
Wales REC 1
REC reference
20/WA/0035
Date of REC Opinion
13 Feb 2020
REC opinion
Further Information Favourable Opinion