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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IV normal saline; Drug: GLYX-13

• Registration Number: NCT01014650
• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-14
• Study First Posted: 2009-11-17
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV normal saline	IV normal saline	Single IV dose of normal saline as a control for safety and tolerability observations
SC GLYX-13	GLYX-13	Single SC dose
IV GLYX-13	GLYX-13	Single IV dose of GLYX-13

Primary Outcome Measures

Name	Time	Method
Observed and laboratory-confirmed safety	four weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States