Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers

Study Identifier
NRX1074-C-101
CT.gov Identifier
NCT01856556
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • NRX-1074
  • Placebo
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 55 Years
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Lotus Clinical Research
    Pasadena, California, United States, 91105
    Status
    Not applicable