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

NeuroGenetic Pharmaceuticals Inc1 site in 1 country40 target enrollmentMarch 2015

ConditionsAlzheimer's Disease

InterventionsNGP 555

DrugsNGP 555

Overview

Phase: Phase 1
Intervention: NGP 555
Conditions: Alzheimer's Disease
Sponsor: NeuroGenetic Pharmaceuticals Inc
Enrollment: 40
Locations: 1
Primary Endpoint: Number of subjects with adverse events as a measure of safety and tolerability
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NeuroGenetic Pharmaceuticals Inc

Responsible Party

Sponsor

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.