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

Denali Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DNL343; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04581772

DNLI-F-0002

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Cohort A

Experimental group

Treatment:

Drug: DNL343

Drug: DNL343

Drug: Placebo

Cohort B

Experimental group

Treatment:

Drug: DNL343

Drug: DNL343

Drug: Placebo

Cohort C

Experimental group

Treatment:

Drug: DNL343

Drug: DNL343