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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01014650

Run by

Naurex, Inc, an affiliate of Allergan plc

People needed

53

Starts

2009-11-01

Expected to finish

2015-10-01

Last updated by the study team

2016-02-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• clinical laboratory values < 2x the upper limit of normal
• ability to understand the requirements of the study and provide informed consent

You may not qualify if…

• 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

Where it is running

• Lotus Clinical Research — Pasadena, California, United States

Full record on ClinicalTrials.gov

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