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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Naurex, Inc
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc
ClinicalTrials.gov Identifier:
NCT01014650
First received: November 13, 2009
Last updated: April 1, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Naurex, Inc:
glycine site partial agonist
normal volunteers
safety in normal volunteers

ClinicalTrials.gov processed this record on September 29, 2014