Pharmacokinetic and Pharmacodynamic Study of AMX0035 in Patients With ALS
NCT04987671 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2023-07-24
Summary
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic effect after a single dose or at steady state after multiple doses of AMX0035 in adults with sporadic ALS.
Conditions
Interventions
- DRUG
-
AMX0035
Fixed dose combination of Sodium Phenylbutyrate and taurursodiol.
Sponsors & Collaborators
-
Amylyx Pharmaceuticals Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-05
- Primary Completion
- 2022-05-11
- Completion
- 2023-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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