Back to resultsA Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B
Primary Purpose
Huntington Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAGE-718
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Sage Investigational Site
- Sage Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAGE-718
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.
Percentage of participants with change from baseline in vital signs.
Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
Percentage of participants with change from baseline in clinical laboratory parameters.
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).
Secondary Outcome Measures
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC].
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax].
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03787758
Brief Title
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
Detailed Description
This posting addresses Part B
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAGE-718
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SAGE-718
Intervention Description
SAGE-718
Primary Outcome Measure Information:
Title
Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.
Time Frame
21 Days
Title
Percentage of participants with change from baseline in vital signs.
Time Frame
21 Days
Title
Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
Time Frame
21 Days
Title
Percentage of participants with change from baseline in clinical laboratory parameters.
Time Frame
21 Days
Title
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC].
Time Frame
17 Days
Title
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].
Time Frame
17 Days
Title
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax].
Time Frame
17 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Sage Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Sage Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Learn more about this trial
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B
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