This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind study of 28 days, followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL343 in participants with amyotrophic lateral sclerosis (ALS)
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
HonorHealth
Scottsdale, Arizona, United States
University of California at San Diego
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
PPD Orlando
Orlando, Florida, United States
Incidence of treatment-emergent adverse events (TEAEs) throughout the double-blind period
Time frame: 28 Days
PK parameter: Maximum concentration (Cmax) of DNL343 in plasma
Time frame: 19 months
PK parameter: Time to reach maximum concentration (tmax) of DNL343 in plasma
Time frame: 19 months
PK parameter: Trough concentration (Ctrough) of DNL343 in plasma
Time frame: 19 months
PK parameter: Area under the concentration-time curve from time zero to 24 hours (AUC24) of DNL343 in plasma
Time frame: 19 months
Cerebrospinal fluid-to-plasma concentration ratio of DNL343 following multiple oral doses
Time frame: 19 months
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Emory University
Atlanta, Georgia, United States
Atrium Health Neurosciences Institute
Charlotte, North Carolina, United States
Centre for Human Drug Research (CHDR)
Leiden, South Holland, Netherlands