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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03331900
Other study ID # COR388-001
Secondary ID
Status Completed
Phase Phase 1
First received October 23, 2017
Last updated April 17, 2018
Start date December 11, 2017
Est. completion date April 2, 2018

Study information

Verified date April 2018
Source Cortexyme Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date April 2, 2018
Est. primary completion date February 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Major Inclusion Criteria:

1. Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from Day -1 through 28 days after the dose of study drug;

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

3. Body mass index (BMI) =19 to =32 kg/m2;

4. Good health as determined by the absence of clinically significant deviation from normal, by medical history, physical examination, laboratory reports, and 12-lead electrocardiogram (ECG) prior to enrollment;

5. Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study;

6. Able to understand and willing to comply with all study requirements, and follow the study medication regimen.

Major Exclusion Criteria:

1. History or current evidence of cardiac, hepatic, renal, pulmonary, endocrine, neurologic, gastrointestinal, hematologic, oncologic, infectious, or psychiatric disease as determined by screening history, physical examination, laboratory reports, or 12-lead ECG;

2. Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential);

3. Use of any prescription drug within 14 days prior to the first dose of the study (with the exception of hormonal contraceptives for females of childbearing potential);

4. Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study;

5. History of significant allergic reaction to any drug;

6. Participation in another investigational new drug research study within the 30 days prior to the first dose of the study;

7. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator;

8. Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
COR388
Administered as oral capsule
Placebo
Administered as oral capsule

Locations

Country Name City State
United States Medpace Clinical Pharmacology Unit Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Cortexyme Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration curve (AUC) Analysis of AUC 72 hours
Primary Maximum observed plasma concentration (Cmax) Analysis of Cmax 72 hours
Primary Time of the first occurrence of the maximum observed plasma concentration (Tmax) Analysis of Tmax 72 hours
Secondary Incidence of treatment emergent adverse events Assessment of the incidence and severity of treatment-emergent adverse events. 72 Hours
Secondary Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin). Assessment of changes in serum chemistry measures. 72 hours
Secondary Changes in hematology lab measures (RBC, Hgb, Hct). Assessment of changes in hematology measures. 72 hours
Secondary Changes in urinalysis lab parameters (pH, specific gravity, glucose). Assessment of changes in urinalysis parameters. 72 hours
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