Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers
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
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2009
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 22, 2016
February 1, 2016
5.9 years
November 13, 2009
February 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Observed and laboratory-confirmed safety
four weeks
Secondary Outcomes (1)
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
Study Arms (3)
IV normal saline
PLACEBO COMPARATORSingle IV dose of normal saline as a control for safety and tolerability observations
IV GLYX-13
EXPERIMENTALSingle IV dose of GLYX-13
SC GLYX-13
EXPERIMENTALSingle SC dose
Interventions
single IV or SC dose
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lotus Clinical Research
Pasadena, California, 91105, United States
Related Publications (1)
Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93.
PMID: 25782764DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Neil Singla, MD
Lotus Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 17, 2009
Study Start
November 1, 2009
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 22, 2016
Record last verified: 2016-02