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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Naurex, Inc; Naurex, Inc, an affiliate of Allergan plc
• Treatments: Glycine

Criteria

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