A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

A Phase 1 Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability, Effect of Food, Palatability, and Safety of Various DNL343 Oral Formulations in Healthy Participants

This is a Phase 1 relative bioavailability study carried out in approximately 24 healthy male subjects and healthy female subjects of non childbearing potential to investigate the effects of formulation and food on the safety, tolerability, and pharmacokinetics (PK) of DNL343.

Key Inclusion Criteria:

• Body mass index (BMI) ≥18.5 to < 30 kg/m2 and body weight of at least 50 kg
• For women: Must have been surgically sterilized or be postmenopausal.

Key Exclusion Criteria:

• History of clinically significant endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
• History of malignancy, except fully resected basal cell carcinoma
• History of clinically significant neurologic or psychiatric diseases; head trauma with loss of consciousness; or clinically significant depression or suicidal ideation