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Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose) | Clinical Trials | Clareo Health

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Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)

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

NCT02534480•NeuroGenetic Pharmaceuticals Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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.
+7 more criteria

Locations (1)

WCCT

Cypress, California, United States

Key Dates

Start Date

March 1, 2015

Primary Completion Date

October 1, 2015

Completion Date

November 1, 2015

Last Updated

January 13, 2016

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

NGP 555

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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