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Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Volunteers (14 Day Multiple Ascending Dose)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02537938
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : March 29, 2017
WCCT Global
Information provided by (Responsible Party):
NeuroGenetic Pharmaceuticals Inc

Brief Summary:
This study involves the use of an investigational drug called NGP 555. In each group of healthy subjects, 2 people will receive placebo and 6 people will receive NGP 555.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: NGP 555 Phase 1

Detailed Description:

The purpose of this research study is to determine the safety, tolerability, and pharmacokinetics (PK) of multiple (14 days), oral doses of NGP 555 in healthy volunteers.

NGP 555 has been created for the treatment of Alzheimer's disease (AD). NGP 555 is being developed to prevent Abeta 42 amyloid formation, a protein that is likely a key factor in the development of AD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-Controlled, Double-blind, Parallel-Group, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered NGP 555 in Healthy Subjects
Study Start Date : January 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NGP 555
NGP 555 given once a day for 14 days as a capsule; 100 mg, 200 mg, or 400 mg
Drug: NGP 555
No Intervention: Placebo
Placebo comparator given once a day for 14 days as a capsule.

Primary Outcome Measures :
  1. Number of adverse events or safety outcomes [ Time Frame: Baseline to 23 days ]
    Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male and female volunteers aged 40-65 yrs and in good health as determined by medical history, physical examination, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and investigator judgement
  2. Volunteer voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures
  3. Female volunteers who are post-menopausal or surgically sterile
  4. Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception
  5. Male healthy volunteers willing to use barrier contraception (i.e., condoms) even if their partners are post-menopausal, surgically sterile or are using acceptable contraceptive methods
  6. Body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 32.0 kg/m2

Exclusion Criteria:

  1. Personal history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse)
  2. Any concurrent disease or condition that, in the opinion of the Investigator, would make the volunteer unsuitable for participation in the clinical study
  3. Volunteer has history of alcohol and/or illicit drug abuse within two years of entry
  4. Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, anxiety or delusions)
  5. History of cerebrovascular events or non-vasovagal related loss of consciousness
  6. History of cardiac arrhythmias, ischemic heart disease, cerebrovascular disease.
  7. Hepatic impairment as defined by >1.3 times the upper limit of normal ranges of serum liver enzymes
  8. Renal impairment as defined by >1.3 abnormal ranges of serum creatinine
  9. Abnormal blood pressure
  10. Abnormal cardiovascular parameters
  11. Volunteers with abnormally low serum B12, folate or abnormal thyroid function tests
  12. Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
  13. Positive urine test for alcohol or drugs
  14. Any suicidal behavior in the last 2 years
  15. Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
  16. Volunteers unwilling to avoid consumption of coffee and caffeine containing beverages
  17. Unable to abstain from smoking (or other nicotine use)
  18. Donation of blood (> 500 mL) or blood products within 2 months
  19. Volunteers who take prohibited medications
  20. Use of an investigational drug within 30 days prior to Screening (Visit 1)
  21. Unwilling to abstain from vigorous exercise
  22. Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests
  23. Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study
  24. Volunteer is unlikely to comply with the protocol requirements, instructions and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visit and improbability of completing the clinical study)
  25. Volunteer has medical conditions that are unstable or which, in the clinical opinion of the Investigator, may interfere with study procedures or volunteer safety. Volunteers with the following stable medical conditions, adequately controlled with stable doses of concomitant medications, need not be excluded if in the opinion of the Investigator, their conditions do not compromise volunteer safety or study procedures:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02537938

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United States, California
WCCT Global
Cypress, California, United States, 90630
Sponsors and Collaborators
NeuroGenetic Pharmaceuticals Inc
WCCT Global
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Principal Investigator: Apinya Vutikkilaird, DO WCCT
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Responsible Party: NeuroGenetic Pharmaceuticals Inc Identifier: NCT02537938    
Other Study ID Numbers: NGP 555-002
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders