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Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

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ClinicalTrials.gov Identifier: NCT01856556
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: NRX-1074 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: NRX-1074, 1 mg
1 mg IV
Drug: NRX-1074
Single IV or PO administration
Other Name: NMDA receptor functional glycine-site partial agonist

Placebo Comparator: Placebo
Saline
Drug: Placebo
Single IV or PO placebo administration

Experimental: NRX-1074, 5 mg
5 mg IV
Drug: NRX-1074
Single IV or PO administration
Other Name: NMDA receptor functional glycine-site partial agonist

Experimental: NRX-1074, 10 mg IV
10 mg
Drug: NRX-1074
Single IV or PO administration
Other Name: NMDA receptor functional glycine-site partial agonist

Experimental: NRX-1074, 50 mg IV
50 mg
Drug: NRX-1074
Single IV or PO administration
Other Name: NMDA receptor functional glycine-site partial agonist

Experimental: NRX-1074, 25 mg PO
25 mg
Drug: NRX-1074
Single IV or PO administration
Other Name: NMDA receptor functional glycine-site partial agonist

Experimental: NRX-1074, 125 mg PO
125 mg
Drug: NRX-1074
Single IV or PO administration
Other Name: NMDA receptor functional glycine-site partial agonist




Primary Outcome Measures :
  1. Observed and laboratory-confirmed safety [ Time Frame: 28 days ]

Secondary Outcome Measures :
  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. [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856556


Locations
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United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Principal Investigator: Grace Ting, MD Lotus Clinical Research

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT01856556     History of Changes
Other Study ID Numbers: NRX1074-C-101
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
safety
tolerability
pharmacokinetics