A Multiple Ascending Dose Study of COR388



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 80
Updated:11/9/2018
Start Date:March 6, 2018
End Date:October 15, 2018

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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease

The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to
assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy
male and female subjects and a cohort of Alzheimer's disease subjects.

The study will enroll 3 cohorts of 8 healthy subjects ≥55 and ≤80 years of age at the
Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects ≥55 and ≤80 years of age.
Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while
confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28
days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.

Inclusion Criteria:

- Male or female subjects ≥55 years to ≤80 years of age, at the time of consent;

- Males of reproductive potential must agree to use double-barrier contraceptive
measures or avoid intercourse from the first dose of study drug through 90 days after
the last dose of study drug.

- Females of child-bearing potential must be non-lactating, have negative serum
pregnancy test results at Screening and negative urine pregnancy test results at Day
-1; agree to use double-barrier or hormonal contraceptive measures or avoid
intercourse from Day -10 through 28 days after the last dose of study drug.

- Stable doses of medications used for stable chronic illnesses that are not prohibited
by the protocol are allowed as long as the dose has been stable for 30 days prior to
Screening, and no changes are expected during participation in the study;

- Body mass index ≥19 kg/m2 to ≤35 kg/m2 at Screening;

- Good general health as determined by medical history, physical examination, laboratory
reports, and 12-lead ECG prior to enrollment;

- Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission
and for the duration of the study;

- Able to swallow capsules;

- Fluent in, and able to read and comprehend, the English language;

Cohort 4 Only:

- Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score ≥14
and ≤25;

- Must have moderate to severe periodontitis according to the CDC-AAP criteria as
determined by the study dentist during the screening oral examination;

- If applicable, have a primary caregiver willing to accept responsibility for
supervising the treatment (eg, administering study drug) and assessing the condition
of the subject throughout the study in accordance with all protocol requirements.

- Provide, if mentally competent and willing, written informed consent. If the subject
is not able to provide written informed consent, written informed consent must be
obtained from a legally authorized representative on the subject's behalf, and verbal
assent may be obtained from the subject. In addition, if the subject has a caregiver,
the caregiver will be required to provide written informed consent prior to the
subject's participation in the study.

Exclusion Criteria:

- History or current evidence of clinically significant arrhythmia, heart failure, or
hypotension in the Investigator's judgment;

- History or current evidence of clinically significant liver disease in the
Investigator's judgment;

- Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50
mL/min/1.73m2 at Screening;

- Subjects who received any treatment for periodontitis in the last 90 days including
systemic or local antibiotics (eg, PerioChip®), scaling, root planing, or other
surgical treatments;

- Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history
of major stroke;

- Active, or recent history of, systemic infection within 30 days prior to Screening
that required treatment with antibiotics for longer than 1 week;

- History or current evidence of psychiatric or emotional problems that would invalidate
giving informed consent or limit the ability of the subject to comply with study
requirements;

- History of systemic allergic reaction to any drug that is considered significant by
the Investigator;

- History of alcohol or drug abuse or dependence within 12 months of Screening, as
determined by the Investigator;

- Positive alcohol screen at Screening or on Day -1;

- Positive urine screen for prohibited drugs

- Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface
antigen, or hepatitis C virus antibodies at Screening;

- Any conditions that, in the opinion of the Investigator, would make the subject
unsuitable for enrollment, could interfere with the subject's participation in or
completion of the study, or could interfere with interpretation of study results;

- Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed
clinically significant by the Investigator;

- The use of any prohibited medication that cannot be stopped or replaced safely, based
on the judgment of the Investigator; or

- Participation in another investigational new drug research study involving small
molecule drugs within 30 days or biological drugs within 60 days prior to the first
dose of study drug.
We found this trial at
3
sites
100 West Gore Street
Orlando, Florida 32806
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Cincinnati, Ohio 45212
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Cincinnati, OH
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San Diego, California 92103
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San Diego, CA
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