Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

A Randomized, Double-Blind, Placebo-Controlled Single Intravenous and Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers

The primary objective of this study is to evaluate the safety and tolerability of a single intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings and subject-reported symptoms.

The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal elimination through urine concentration of NRX-1074 through 24 hours following dosing.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NRX-1074; Drug: Placebo

Detailed Description

Randomized, double-blind, placebo-controlled, single ascending dose level study. On Day 1, eligibility of each subject will be confirmed, physical examination will be performed, and blood and urine for laboratories will be obtained. Each subject will be randomized, then will receive either a single IV, SC or IN dose of GLYX-13 or placebo.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects
2. Aged 18 to 55 years
3. For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control from date of screening to at least 30 days after the last dose of study drugIf of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
4. Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
5. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline	Drug: Placebo; Single IV or PO placebo administration
Experimental: NRX-1074, 1 mg; 1 mg IV	Drug: NRX-1074; Single IV or PO administration; Other Names: NMDA receptor functional glycine-site partial agonist
Experimental: NRX-1074, 5 mg; 5 mg IV	Drug: NRX-1074; Single IV or PO administration; Other Names: NMDA receptor functional glycine-site partial agonist
Experimental: NRX-1074, 10 mg IV; 10 mg	Drug: NRX-1074; Single IV or PO administration; Other Names: NMDA receptor functional glycine-site partial agonist
Experimental: NRX-1074, 50 mg IV; 50 mg	Drug: NRX-1074; Single IV or PO administration; Other Names: NMDA receptor functional glycine-site partial agonist
Experimental: NRX-1074, 25 mg PO; 25 mg	Drug: NRX-1074; Single IV or PO administration; Other Names: NMDA receptor functional glycine-site partial agonist
Experimental: NRX-1074, 125 mg PO; 125 mg	Drug: NRX-1074; Single IV or PO administration; Other Names: NMDA receptor functional glycine-site partial agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Observed and laboratory-confirmed safety	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Naurex, Inc, an affiliate of Allergan plc
• Investigators: Principal Investigator: Grace Ting, MD, Lotus Clinical Research

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Estimate): January 26, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: tolerability; safety; pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Glycine Agents; Glycine
• Other Study ID Numbers: NRX1074-C-101