A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2024-06-05

Brief Summary

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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)

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Detailed Description

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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.).

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DNL343 (High Dose)

Group Type EXPERIMENTAL

DNL343

Intervention Type DRUG

Oral repeating dose

DNL343 (Low Dose)

Group Type EXPERIMENTAL

DNL343

Intervention Type DRUG

Oral repeating dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral repeating dose

Interventions

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DNL343

Oral repeating dose

Intervention Type DRUG

Placebo

Oral repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of sporadic or familial ALS
* ≤ 4 years since ALS symptom onset
* Stable doses of approved ALS treatments (riluzole and/or edaravone) for at least 2 months prior to screening
* Participants must be able to swallow the study intervention
* Vital capacity \>50% predicted at screening
* Women must have been surgically sterilized, be postmenopausal, or for participants of childbearing potential, must not be pregnant, and both the participant and the male partner must use highly effective contraception
* Men, and sex partner if a woman of childbearing potential, must use highly effective contraception

Exclusion Criteria

* Any history of unstable or poorly controlled psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
* Positive serum pregnancy test or currently lactating or breastfeeding
* History of malignancy within 5 years
* History of clinically significant neurologic disorders other than ALS

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No