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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03787758 |
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Date of registration:
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17/12/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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February 28, 2019 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03787758 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Huntington Disease
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Intervention(s)
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Drug: SAGE-718
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Primary Outcome(s)
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Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).
[Time Frame: 21 Days]
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Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
[Time Frame: 21 Days]
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Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.
[Time Frame: 21 Days]
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Percentage of participants with change from baseline in clinical laboratory parameters.
[Time Frame: 21 Days]
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Percentage of participants with change from baseline in vital signs.
[Time Frame: 21 Days]
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Secondary Outcome(s)
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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]
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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]
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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]
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Secondary ID(s)
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718-CLP-102 B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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