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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2013
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedJanuary 26, 2016
January 1, 2016
1.5 years
May 13, 2013
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Observed and laboratory-confirmed safety
28 days
Secondary Outcomes (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.
24 hours
Study Arms (7)
NRX-1074, 1 mg
EXPERIMENTAL1 mg IV
Placebo
PLACEBO COMPARATORSaline
NRX-1074, 5 mg
EXPERIMENTAL5 mg IV
NRX-1074, 10 mg IV
EXPERIMENTAL10 mg
NRX-1074, 50 mg IV
EXPERIMENTAL50 mg
NRX-1074, 25 mg PO
EXPERIMENTAL25 mg
NRX-1074, 125 mg PO
EXPERIMENTAL125 mg
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects
- Aged 18 to 55 years
- 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.
- Clinical laboratory values less than or equal to 2 times the upper limit of normal (ULN) or deemed not clinically significant by the Investigator.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lotus Clinical Research
Pasadena, California, 91105, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Grace Ting, MD
Lotus Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 17, 2013
Study Start
May 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
January 26, 2016
Record last verified: 2016-01