Healthy volunteers Not Applicable
Conditions
Interventions
Single oral dose of DNL343 without and with repeating oral doses of itraconazole.
The total duration of each participant’s involvement in the study will be approximately 73 days from screening throug
Sponsors
Denali Therapeutics (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male participants and healthy female participants of non-childbearing potential 2. Aged =18 to =55 years 3. Body mass index (BMI) of =18.5 to =30 kg/m² 4. Body weight of =50 kg
Exclusion criteria
Exclusion criteria: 1. History of clinically significant endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders 2. History of malignancy, except fully resected basal cell carcinoma 3. History of clinically significant neurological or psychiatric diseases 4. History of serious adverse reaction or serious hypersensitivity to any drug, or history of allergy to any component of the DNL343 or itraconazole products 5. Are pregnant (ie, positive pregnancy test) or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DNL343 PK parameters, as measured by laboratory analysis of plasma concentrations from blood samples, including, but not limited to, the following: 1. Maximum concentration (Cmax) 2. Area under the concentration-time curve from time zero to infinity (AUC8) 3. Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) [Timeframe: Multiple timepoints over 45 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) as reported by the participant (or, when appropriate, by a caregiver, a surrogate, or the participant's legally authorized representative) [Timeframe: Continuously over 45 days] | — |
Countries
United Kingdom, Wales
Contacts
Public ContactGabrielle;Clinical Trials Disclosures Group Brill;-
;
Outcome results
None listed