A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers

Denali Therapeutics Inc.122 enrolled

Overview

This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

122

Conditions

Healthy Volunteers

Interventions

DNL201DRUG

Oral dose(s)

PlaceboDRUG

Oral dose(s)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening * In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements * Women of non-childbearing potential and men using contraceptive measures Key Exclusion Criteria: * History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders * History of asthma, chronic obstructive pulmonary disease, or emphysema * Clinically significant neurologic disorder * History of stomach or intestinal surgery or resection * History of malignancy

Locations (1)

Clinical Site(s)

Dallas, Texas, United States

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs

Time frame: Up to 20 days

PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma

Time frame: Up to 10 days

PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma

Time frame: Up to 10 days

PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only)

Time frame: Up to 10 days

PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma

Time frame: Up to 10 days

PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only)

Time frame: Up to 10 days

PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma

Time frame: Up to 10 days

Secondary Outcomes

Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)

Time frame: Up to 10 days

The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935

Time frame: Up to 10 days

Data from ClinicalTrials.gov

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