NCT03787758

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	SAGE-718	SAGE-718

Timeline

• Start date: 2019-02-28
• Primary completion: 2019-10-07
• Completion: 2019-10-07
• First posted: 2018-12-26
• Last updated: 2025-09-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study