Single Ascending Dose Safety, Tolerability and Pharmacokinetics Study of GLYX-13 in Normal Volunteers
This study is currently recruiting participants.
Verified September 2012 by Naurex, Inc
Sponsor:
Naurex, Inc
Information provided by (Responsible Party):
Naurex, Inc
ClinicalTrials.gov Identifier:
NCT01014650
First received: November 13, 2009
Last updated: May 14, 2013
Last verified: September 2012
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Purpose
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single IV dose of GLYX-13, an NMDA receptor glycine site functional partial agonist, in normal, healthy human volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: GLYX-13 Drug: IV normal saline |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Naurex, Inc:
Primary Outcome Measures:
- Observed and laboratory-confirmed safety [ Time Frame: four weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: IV normal saline
Single IV dose of normal saline as a control for safety and tolerability observations
|
Drug: IV normal saline
Single IV dose of normal saline
|
|
Experimental: IV GLYX-13
Single IV dose of GLYX-13
|
Drug: GLYX-13
single IV or SC dose
Other Name: NMDA receptor glycine site partial agonist
|
|
Experimental: SC GLYX-13
Single SC dose
|
Drug: GLYX-13
single IV or SC dose
Other Name: NMDA receptor glycine site partial agonist
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014650
Contacts
| Contact: Michelle D Ababa, MD | 626-397-2340 | info@lotuscr.com |
| Contact: Neil Singla, MD | 877-568-8727 | info@lotuscr.com |
Locations
| United States, California | |
| Lotus Clinical Research | Recruiting |
| Pasadena, California, United States, 91105 | |
| Contact: Michele D Obaba, MD 626-397-2390 info@lotuscr.com | |
| Contact: Neil Singla, MD 877-568-8727 info@lotuscr.com | |
| Principal Investigator: Michelle D Obaba, MD | |
Sponsors and Collaborators
Naurex, Inc
Investigators
| Study Director: | Neil Singla, MD | Lotus Clinical Research |
More Information
No publications provided
| Responsible Party: | Naurex, Inc |
| ClinicalTrials.gov Identifier: | NCT01014650 History of Changes |
| Other Study ID Numbers: | GLYX13-C-101 |
| Study First Received: | November 13, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Naurex, Inc:
|
glycine site partial agonist normal volunteers safety in normal volunteers |
Additional relevant MeSH terms:
|
Glycine Glycine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013