Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189

November 17, 2011 updated by: Neuralstem Inc.

A Phase 1, Randomized, Subject Single Blinded, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of NSI-189 Phosphate in Healthy Subjects

This is a subject single blinded, randomized, placebo-controlled, single dose, first-time-in-human study with three or more ascending cohorts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each subject will undergo Screening (Day -28 to Day -2). Subjects will return to the clinical site on Day -1, be admitted to the unit, and eligibility will be reconfirmed. Eligible subjects will receive a single dose of investigational medicinal product (IMP, NSI-189 Phosphate or Placebo) on Day 1 and will be followed for safety and PK until discharge on Day 3. Subjects who are experiencing any significant AEs that are considered possibly related to study drug will be kept at the unit for an additional day (or longer) until the event resolves or it is considered medically safe for the subject to be discharged. Subjects will have a telephone Follow-up on Day 4 and return to the unit on Day 7 (± 1) for End-of-study. Participation of an individual subject may last up to 36 days from the time of Screening until the End-of-study.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • California Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A subject must meet all of the following criteria:

    1. Subject has the ability to understand the purpose and risks of the study and to provide signed and dated informed consent.
    2. Males and females between 18 to 55 years of age, inclusive, at the time of informed consent.

    3. The following applies to female subjects:

      • Non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone >40 U/L).

    4. The following applies to male subjects:

      • Male subjects with a female partner of childbearing potential will be required to use an effective method of birth control or practice abstinence during this study and for 3 months following discontinuation of IMP.

    5. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year) and by negative urine cotinine test at screening and Day -1.
    6. BMI ≥ 19.5 and ≤30.0 kg/m2, at screening. Bodyweight must be >50 kg.
    7. Healthy, determined by pre-study medical evaluation and investigator discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).

Exclusion Criteria:

  1. Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, dermatological or psychiatric disorder(s), or other major disease as determined by the Investigator or designee.
  2. History of seizures including febrile seizures, loss of consciousness, or any clinically significant finding on the neurologic examination.
  3. Clinically significant abnormal clinical chemistry values, as determined by the Investigator.
  4. Clinically significant (as determined by the Investigator) 12-lead ECG abnormalities, including corrected QT interval using Bazett's correction method of >450 msec for males and >470 msec for females.
  5. History of severe allergic or anaphylactic reactions.
  6. Subjects who have plans to undergo elective procedures/surgeries at any time during the study through the follow-up visits.
  7. A positive screening test for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCVAb), hepatitis B core antibody (HBcAb), or hepatitis B surface antigen (HBsAg).
  8. Serious infection (e.g. pneumonia, septicemia) as determined by the Investigator within 3 months prior to Day -1.
  9. Fever or bacterial, or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
  10. Treatment with any prescribed medication within 28 days prior to Day -1.
  11. Treatment with any over-the-counter products (OTC), including herbal and/or alternative health preparations and procedures within the 14 days prior to Day -1. Note: Intermittent treatment with acetaminophen [≤1000 mg/day] and/or ibuprofen [≤400 mg/day] is permitted.
  12. Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational product or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1.
  13. Any live or attenuated immunization/vaccination within 1 month prior to the study drug administration or planned to occur during the study period.
  14. Donation of blood (>500 mL) or blood products within 1 month prior to screening.
  15. History of alcohol or substance abuse (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) (as determined by the Investigator).
  16. Vigorous exercise (as determined by the Investigator) within 48 hours prior to the study drug administration.
  17. Inability to comply with study requirements.
  18. Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
  19. Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the clinical study.
  20. Subject unwilling to avoid consumption of coffee and caffeine containing beverages within 48 hours prior to Day -1 until discharge from the clinical site.
  21. Use of an investigational product within 30 days prior to Day -1.
  22. Subject is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
  23. Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions.
  24. Subject has previously been enrolled in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
Drug: NSI-189 Phosphate
Once daily oral administration
Experimental: Dose 2
Drug: NSI-189 Phosphate
Once daily oral administration
Experimental: Dose 3
Drug: NSI-189 Phosphate
Once daily oral administration
Experimental: Dose 4
Drug: NSI-189 Phosphate
Once daily oral administration
Experimental: Dose 5
Drug: NSI-189 Phosphate
Once daily oral administration
Experimental: Dose 6
Drug: NSI-189 Phosphate
Once daily oral administration
Experimental: Dose 7
Drug: NSI-189 Phosphate
Once daily oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of drug assessed by number and severity of adverse events in drug vs placebo groups
Time Frame: 7 days
Values for vital signs, standard physical examination, ECG, EEG and standard clinical laboratory tests (haematology and biochemistry), and for standard neurological exam and the Columbia Suicide Severity Rating Scale will be compared between NS189 and placebo.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of NS189 will be determined by plasma sample collection at various timepoints post-dosing, and measuring concentration of drug over time.
Time Frame: 7 days
Concentration of NS189 will be measured in plasma and standard PK values determined: AUC, Cmax, Tmax, T1/2, CL, Vz
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuralstem Inc.

Investigators

  • Study Director: Karl Johe, PhD, Neuralstem Inc.
  • Principal Investigator: David Han, MD, California Clinical Trials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

March 5, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 17, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NS2010-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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