A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B
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 With an Open-label Cohort of Patients With Huntington's Disease
1 other identifier
interventional
6
1 country
2
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2019
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2019
CompletedSeptember 17, 2025
January 1, 2022
7 months
December 17, 2018
September 11, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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
Secondary Outcomes (3)
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].
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
Study Arms (1)
SAGE-718
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject is positive for mutant HTT (documented CAG repeats ≥ 40 units).
- Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
You may not qualify if:
- Subject has any clinically significant abnormal finding on the physical exam at screening or admission.
- Subject has a history or presence of a neurologic disease or condition (other than Huntington's disease), including but not limited to severe chorea, epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
- Subject has a family history of epilepsy.
- Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sage Investigational Site
Long Beach, California, 90806, United States
Sage Investigational Site
Marlton, New Jersey, 08053, United States
Related Publications (1)
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.
PMID: 38988035DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2018
First Posted
December 26, 2018
Study Start
February 28, 2019
Primary Completion
October 7, 2019
Study Completion
October 7, 2019
Last Updated
September 17, 2025
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.