Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NGP 555
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer's Disease focused on measuring Amyloid
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
- Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device.
- Male healthy volunteers willing to use barrier contraception.
- Body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2
Exclusion Criteria:
- 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)
- Any concurrent disease or condition that, in the opinion of the Investigator, would make the volunteer unsuitable for participation in the clinical study
- History of alcohol and/or illicit drug abuse within two years of entry
- Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, anxiety or delusions)
- History of cerebrovascular events or non-vasovagal related loss of consciousness
- History of cardiac arrhythmias, ischemic heart disease or cerebrovascular disease
- Hepatic impairment as defined by >1.3 times the upper limit of normal ranges of serum liver enzymes
- Renal impairment as defined by abnormal ranges of serum creatinine.
- 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])
- Corrected QT interval (QTc) values of > 450 ms for males and > 470 ms for females.
- Volunteers with abnormally low serum B12, folate or abnormal thyroid function tests
- Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
- Positive urine test for alcohol or drugs
- Suicidal ideation
- Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
- Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests
- Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study
Sites / Locations
- WCCT
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
NGP 555 25 mg
NGP 555 50 mg
NGP 555 100 mg
NGP 555 200 mg
NGP 555 300 mg
Arm Description
NGP 555 25 mg capsule and placebo by mouth once per day
NGP 555 50 mg capsule and placebo by mouth once per day
NGP 555 100 mg capsule and placebo by mouth once per day
NGP 555 200 mg capsule and placebo by mouth once per day
NGP 555 300 mg capsule and placebo by mouth once per day
Outcomes
Primary Outcome Measures
Number of subjects with adverse events as a measure of safety and tolerability
Secondary Outcome Measures
Full Information
NCT ID
NCT02534480
First Posted
April 27, 2015
Last Updated
January 12, 2016
Sponsor
NeuroGenetic Pharmaceuticals Inc
1. Study Identification
Unique Protocol Identification Number
NCT02534480
Brief Title
Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroGenetic Pharmaceuticals Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Amyloid
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NGP 555 25 mg
Arm Type
Active Comparator
Arm Description
NGP 555 25 mg capsule and placebo by mouth once per day
Arm Title
NGP 555 50 mg
Arm Type
Active Comparator
Arm Description
NGP 555 50 mg capsule and placebo by mouth once per day
Arm Title
NGP 555 100 mg
Arm Type
Active Comparator
Arm Description
NGP 555 100 mg capsule and placebo by mouth once per day
Arm Title
NGP 555 200 mg
Arm Type
Active Comparator
Arm Description
NGP 555 200 mg capsule and placebo by mouth once per day
Arm Title
NGP 555 300 mg
Arm Type
Active Comparator
Arm Description
NGP 555 300 mg capsule and placebo by mouth once per day
Intervention Type
Drug
Intervention Name(s)
NGP 555
Other Intervention Name(s)
NGP555
Intervention Description
Gamma-secretase modulator for the treatment of Alzheimer's disease
Primary Outcome Measure Information:
Title
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame
0-96 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device.
Male healthy volunteers willing to use barrier contraception.
Body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2
Exclusion Criteria:
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)
Any concurrent disease or condition that, in the opinion of the Investigator, would make the volunteer unsuitable for participation in the clinical study
History of alcohol and/or illicit drug abuse within two years of entry
Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, anxiety or delusions)
History of cerebrovascular events or non-vasovagal related loss of consciousness
History of cardiac arrhythmias, ischemic heart disease or cerebrovascular disease
Hepatic impairment as defined by >1.3 times the upper limit of normal ranges of serum liver enzymes
Renal impairment as defined by abnormal ranges of serum creatinine.
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])
Corrected QT interval (QTc) values of > 450 ms for males and > 470 ms for females.
Volunteers with abnormally low serum B12, folate or abnormal thyroid function tests
Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
Positive urine test for alcohol or drugs
Suicidal ideation
Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests
Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apinya Vutikullird, DO
Organizational Affiliation
WCCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
WCCT
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
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Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)
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