A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects

Supernus Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: SAGE-718

Study type: Interventional

Funder types: Industry

Identifiers

NCT03844906

718-EXM-103

Details and patient eligibility

About

This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening.
2. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.

Exclusion criteria

1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
3. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

SAGE-718

Experimental group

Treatment:

Drug: SAGE-718

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo