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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534480
• Other study ID #: NGP 555-001
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2015
• Last updated: January 12, 2016
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: NeuroGenetic Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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. Suicidal ideation

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

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

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• NGP 555
Gamma-secretase modulator for the treatment of Alzheimer's disease

Locations

Country	Name	City	State
United States	WCCT	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
NeuroGenetic Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events as a measure of safety and tolerability		0-96 hours post-dose