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

NCT02537938 | Completed Phase 1 DMC

• 1 other identifier: NGP 555-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Number of adverse events or safety outcomes

  Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  Baseline to 23 days

Study Arms (2)

NGP 555

EXPERIMENTAL

NGP 555 given once a day for 14 days as a capsule; 100 mg, 200 mg, or 400 mg

Drug: NGP 555

Placebo

NO INTERVENTION

Placebo comparator given once a day for 14 days as a capsule.

Interventions

NGP 555 DRUG

NGP 555

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 post-menopausal or surgically sterile
• Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception
• 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
• Body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 32.0 kg/m2

You may not qualify if:

• 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)
• Any concurrent disease or condition that, in the opinion of the Investigator, would make the volunteer unsuitable for participation in the clinical study
• Volunteer has 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, 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 \>1.3 abnormal ranges of serum creatinine
• Abnormal blood pressure
• Abnormal cardiovascular parameters
• 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
• Any suicidal behavior in the last 2 years
• Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test

Sponsors & Collaborators

• NeuroGenetic Pharmaceuticals Inc: lead
• WCCT Global: collaborator

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Apinya Vutikkilaird, DO

  WCCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 2, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)