Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers

Allergan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IV normal saline; Drug: GLYX-13

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014650

GLYX13-C-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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53 participants in 3 patient groups, including a placebo group

IV normal saline

Placebo Comparator group

Description:

Single IV dose of normal saline as a control for safety and tolerability observations

Treatment:

Drug: IV normal saline

IV GLYX-13

Experimental group

Description:

Single IV dose of GLYX-13

Treatment:

Drug: GLYX-13

SC GLYX-13

Experimental group

Description:

Single SC dose

Treatment:

Drug: GLYX-13