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This study is a phase 1, double-blind, placebo-controlled, multiple ascending dose study to determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)
This posting addresses Part B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAGE-718 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE-718 | Drug | SAGE-718 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. | 21 Days | |
| Percentage of participants with change from baseline in vital signs. | 21 Days | |
| Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities | 21 Days | |
| Percentage of participants with change from baseline in clinical laboratory parameters. | 21 Days | |
| Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS). | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC]. | 17 Days | |
| PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Long Beach | California | 90806 | United States | ||
| Sage Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38988035 | Derived | Koenig A, Lewis M, Wald J, Li S, Varoglu M, Dai J, Sankoh A, Paumier K, Doherty J, Quirk M. Dalzanemdor (SAGE-718), a novel, investigational N-methyl-D-aspartate receptor positive allosteric modulator: Safety, tolerability, and clinical pharmacology in randomized dose-finding studies in healthy participants and an open-label study in participants with Huntington's disease. Clin Transl Sci. 2024 Jul;17(7):e13852. doi: 10.1111/cts.13852. |
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Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 17 Days |
| PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax]. | 17 Days |
| Marlton |
| New Jersey |
| 08053 |
| United States |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |