Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

Allergan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: NRX-1074

Study type: Interventional

Funder types: Industry

Identifiers

NCT01856556

NRX1074-C-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 7 patient groups, including a placebo group

NRX-1074, 1 mg

Experimental group

Description:

1 mg IV

Treatment:

Drug: NRX-1074

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Placebo

NRX-1074, 5 mg

Experimental group

Description:

5 mg IV

Treatment:

Drug: NRX-1074

NRX-1074, 10 mg IV

Experimental group

Description:

10 mg

Treatment:

Drug: NRX-1074

NRX-1074, 50 mg IV

Experimental group

Description:

50 mg

Treatment:

Drug: NRX-1074

NRX-1074, 25 mg PO

Experimental group

Description:

25 mg

Treatment:

Drug: NRX-1074

NRX-1074, 125 mg PO

Experimental group

Description:

125 mg

Treatment:

Drug: NRX-1074