Status:
COMPLETED
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Huntington Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Detailed Description
This posting addresses Part B
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03787758
Start Date
February 28 2019
End Date
October 7 2019
Last Update
September 17 2025
Active Locations (2)
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1
Sage Investigational Site
Long Beach, California, United States, 90806
2
Sage Investigational Site
Marlton, New Jersey, United States, 08053