Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NRX-1074; Drug: Placebo

• Registration Number: NCT01856556
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-17
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NRX-1074, 10 mg IV	NRX-1074	10 mg
NRX-1074, 1 mg	NRX-1074	1 mg IV
NRX-1074, 125 mg PO	NRX-1074	125 mg
Placebo	Placebo	Saline
NRX-1074, 50 mg IV	NRX-1074	50 mg
NRX-1074, 25 mg PO	NRX-1074	25 mg
NRX-1074, 5 mg	NRX-1074	5 mg IV

Primary Outcome Measures

Name	Time	Method
Observed and laboratory-confirmed safety	28 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States