Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

NCT ID: NCT01856556

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-11-30

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NRX-1074, 1 mg

1 mg IV

Group Type: EXPERIMENTAL

NRX-1074

Intervention Type: DRUG

Single IV or PO administration

Placebo

Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single IV or PO placebo administration

NRX-1074, 5 mg

5 mg IV

Group Type: EXPERIMENTAL

NRX-1074

Intervention Type: DRUG

Single IV or PO administration

NRX-1074, 10 mg IV

10 mg

Group Type: EXPERIMENTAL

NRX-1074

Intervention Type: DRUG

Single IV or PO administration

NRX-1074, 50 mg IV

50 mg

Group Type: EXPERIMENTAL

NRX-1074

Intervention Type: DRUG

Single IV or PO administration

NRX-1074, 25 mg PO

25 mg

Group Type: EXPERIMENTAL

NRX-1074

Intervention Type: DRUG

Single IV or PO administration

NRX-1074, 125 mg PO

125 mg

Group Type: EXPERIMENTAL

NRX-1074

Intervention Type: DRUG

Single IV or PO administration

Interventions

NRX-1074

Single IV or PO administration

Intervention Type: DRUG

Placebo

Single IV or PO placebo administration

Intervention Type: DRUG

Other Intervention Names

NMDA receptor functional glycine-site partial agonist

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Naurex, Inc, an affiliate of Allergan plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace Ting, MD

Role: PRINCIPAL_INVESTIGATOR

Lotus Clinical Research

Locations

Lotus Clinical Research

Pasadena, California, United States

Countries

United States

Other Identifiers

NRX1074-C-101

Identifier Type: -

Identifier Source: org_study_id