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

NCT ID: NCT02537938

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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.

Detailed Description

The purpose of this research study is to determine the safety, tolerability, and pharmacokinetics (PK) of multiple (14 days), oral doses of NGP 555 in healthy volunteers.

NGP 555 has been created for the treatment of Alzheimer's disease (AD). NGP 555 is being developed to prevent Abeta 42 amyloid formation, a protein that is likely a key factor in the development of AD.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

NGP 555

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

Group Type: EXPERIMENTAL

NGP 555

Intervention Type: DRUG

Placebo

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NGP 555

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

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 post-menopausal or surgically sterile

4. Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception

5. 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

6. Body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 32.0 kg/m2

Exclusion Criteria

1. 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)

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. Volunteer has 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, 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 >1.3 abnormal ranges of serum creatinine

9. Abnormal blood pressure

10. Abnormal cardiovascular parameters

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. Any suicidal behavior in the last 2 years

15. Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test

16. Volunteers unwilling to avoid consumption of coffee and caffeine containing beverages

17. Unable to abstain from smoking (or other nicotine use)

18. Donation of blood (> 500 mL) or blood products within 2 months

19. Volunteers who take prohibited medications

20. Use of an investigational drug within 30 days prior to Screening (Visit 1)

21. Unwilling to abstain from vigorous exercise

22. Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests

23. Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study

24. Volunteer is unlikely to comply with the protocol requirements, instructions and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visit and improbability of completing the clinical study)

25. Volunteer has medical conditions that are unstable or which, in the clinical opinion of the Investigator, may interfere with study procedures or volunteer safety. Volunteers with the following stable medical conditions, adequately controlled with stable doses of concomitant medications, need not be excluded if in the opinion of the Investigator, their conditions do not compromise volunteer safety or study procedures:

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

WCCT Global

INDUSTRY

Sponsor Role: collaborator

NeuroGenetic Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Apinya Vutikkilaird, DO

Role: PRINCIPAL_INVESTIGATOR

WCCT

Locations

WCCT Global

Cypress, California, United States

Countries

United States

Other Identifiers

NGP 555-002

Identifier Type: -

Identifier Source: org_study_id