NCT03284931

A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model

A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.

Detailed description

Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4). This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SAGE-217 high dose	high dose
DRUG	Placebo	placebo
DRUG	SAGE-217 low dose	low dose

Timeline

• Start date: 2017-09-14
• Primary completion: 2017-12-04
• Completion: 2017-12-18
• First posted: 2017-09-15
• Last updated: 2023-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study