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A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03787758
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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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)

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: SAGE-718 Phase 1

Detailed Description:
This posting addresses Part B
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 28, 2019
Actual Primary Completion Date : October 7, 2019
Actual Study Completion Date : October 7, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SAGE-718 Drug: SAGE-718
SAGE-718


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. [ Time Frame: 21 Days ]
  2. Percentage of participants with change from baseline in vital signs. [ Time Frame: 21 Days ]
  3. Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities [ Time Frame: 21 Days ]
  4. Percentage of participants with change from baseline in clinical laboratory parameters. [ Time Frame: 21 Days ]
  5. Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS). [ Time Frame: 21 Days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is positive for mutant HTT (documented CAG repeats ≥ 40 units).
  2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.

Exclusion Criteria:

  1. Subject has any clinically significant abnormal finding on the physical exam at screening or admission.
  2. 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.
  3. Subject has a family history of epilepsy.
  4. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787758


Locations
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United States, California
Sage Investigational Site
Long Beach, California, United States, 90806
United States, New Jersey
Sage Investigational Site
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Sage Therapeutics
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03787758    
Other Study ID Numbers: 718-CLP-102 B
First Posted: December 26, 2018    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders