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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|ClinicalTrials.gov Identifier: NCT03787758|
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : January 31, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Huntington Disease||Drug: SAGE-718||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. [ Time Frame: 21 Days ]
- Percentage of participants with change from baseline in vital signs. [ Time Frame: 21 Days ]
- Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities [ Time Frame: 21 Days ]
- Percentage of participants with change from baseline in clinical laboratory parameters. [ Time Frame: 21 Days ]
- Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS). [ Time Frame: 21 Days ]
- 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 ]
- 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 ]
- 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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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
|Responsible Party:||Sage Therapeutics|
|Other Study ID Numbers:||
|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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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