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Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-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.
 
ClinicalTrials.gov Identifier: NCT02534480
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
NeuroGenetic Pharmaceuticals Inc

Brief Summary:
NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.

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

Detailed Description:

NGP 555 is a gamma-secretase modulator with a selective mechanism to reduce Abeta 42 while raising shorter Abeta forms such as Abeta 37 and 38.

NGP 555 is being developed as a preventative disease modifying therapy for Alzheimer's disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered NGP 555 in Healthy Young Volunteers
Study Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NGP 555 25 mg
NGP 555 25 mg capsule and placebo by mouth once per day
Drug: NGP 555
Gamma-secretase modulator for the treatment of Alzheimer's disease
Other Name: NGP555

Active Comparator: NGP 555 50 mg
NGP 555 50 mg capsule and placebo by mouth once per day
Drug: NGP 555
Gamma-secretase modulator for the treatment of Alzheimer's disease
Other Name: NGP555

Active Comparator: NGP 555 100 mg
NGP 555 100 mg capsule and placebo by mouth once per day
Drug: NGP 555
Gamma-secretase modulator for the treatment of Alzheimer's disease
Other Name: NGP555

Active Comparator: NGP 555 200 mg
NGP 555 200 mg capsule and placebo by mouth once per day
Drug: NGP 555
Gamma-secretase modulator for the treatment of Alzheimer's disease
Other Name: NGP555

Active Comparator: NGP 555 300 mg
NGP 555 300 mg capsule and placebo by mouth once per day
Drug: NGP 555
Gamma-secretase modulator for the treatment of Alzheimer's disease
Other Name: NGP555




Primary Outcome Measures :
  1. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: 0-96 hours post-dose ]


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:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female volunteers aged 18-55 yrs and in good health as determined by medical history, physical examination, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and investigator judgment
  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 of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device.
  4. Male healthy volunteers willing to use barrier contraception.
  5. Body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2

Exclusion Criteria:

  1. 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. 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 or 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 abnormal ranges of serum creatinine.
  9. Presence of clinically significant orthostatic hypotension (fall in systolic blood pressure of >20 mmHg or fall diastolic blood pressure of > 10 mmHg; and increase in heart rate by > 20 beats per minute [bpm])
  10. Corrected QT interval (QTc) values of > 450 ms for males and > 470 ms for females.
  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. Suicidal ideation
  15. Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
  16. Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests
  17. Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study

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 ClinicalTrials.gov identifier (NCT number): NCT02534480


Locations
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United States, California
WCCT
Cypress, California, United States, 90630
Sponsors and Collaborators
NeuroGenetic Pharmaceuticals Inc
Investigators
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Principal Investigator: Apinya Vutikullird, DO WCCT
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Responsible Party: NeuroGenetic Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02534480    
Other Study ID Numbers: NGP 555-001
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by NeuroGenetic Pharmaceuticals Inc:
Amyloid
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders