A Randomized, Double-Blind, Placebo-Controlled Single Intravenous Dose, Ascending Dose Level Study of the Safety, Tolerability and Pharmacokinetics of GLYX-13 in Normal Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Observed and laboratory-confirmed safety
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single IV dose of GLYX-13, an N-Methyl-D-aspartate (NMDA) receptor glycine site functional partial agonist, in normal, healthy human volunteers.
Detailed Description
NMDA receptor glycine site partial agonists (GFPAs) have been demonstrated to be efficacious in animal models and/or in early human studies of several Central Nervous System (CNS) diseases including neuropathic pain, major depressive disorder, schizophrenia, Alzheimer's disease, anxiety including posttraumatic stress syndrome, and cognition in Down's syndrome and autism and others, without the psychomimetic side effects of NMDA receptor channel blockers. GLYX-13 has demonstrated a wide therapeutic ratio (500:1) between efficacy and side effects in animals. The purpose of this study is to evaluate the safety and pharmacokinetics of GLYX-13 following a single IV dose.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •clinical laboratory values < 2x the upper limit of normal
- •ability to understand the requirements of the study and provide informed consent
Exclusion Criteria
- •alcohol abuse
- •abuse of illicit substances
- •current smoker
- •currently taking prescription medications (other than for birth control)
- •history of allergy to NMDA receptor ligands
- •received another investigational drug within 30 days
- •psychiatric disease
Arms & Interventions
IV normal saline
Single IV dose of normal saline as a control for safety and tolerability observations
Intervention: IV normal saline (Drug)
IV GLYX-13
Single IV dose of GLYX-13
Intervention: GLYX-13 (Drug)
SC GLYX-13
Single SC dose
Intervention: GLYX-13 (Drug)
Outcomes
Primary Outcomes
Observed and laboratory-confirmed safety
Time Frame: four weeks
Secondary Outcomes
- Plasma concentration of parent drug will be assessed over time to estimate duration of pharmacodynamics in future efficacy trials. Plasma concentration and pharmacokinetics will be related in time to observed side effects.(24 hours)