Phase 1 Study of COR388 HCl in Healthy Volunteers

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study of COR388 HCl in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03303560
• Other study ID #: COR388-001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 2, 2017
• Last updated: October 5, 2017
• Start date: December 2017
• Est. completion date: March 2018

Study information

• Verified date: October 2017
• Source: Cortexyme Inc.
• Contact: n/a
• Is FDA regulated: No
• 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: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects =18 to =55 years of age, at time of consent;

2. 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;

3. 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;

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

5. 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;

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

7. Ability to swallow capsules;

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

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

10. Willing and able to give written informed consent.

Exclusion Criteria:

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

2. Subjects with PR > 200 msec, QRS > 100 msec, supraventricular ectopy or ventricular ectopy detected on the screening ECG.

3. Subjects with a history of 1st, 2nd or 3rd atrioventricular block (AVB), bundle branch block (BBB), or symptomatic ectopy.

4. Clinically significant infection within 3 months of screening as determined by the Investigator;

5. History or current evidence of psychiatric or emotional problems which would invalidate giving Informed Consent or limit the ability of the subject to comply with study requirements;

6. Systolic blood pressure (BP) of less than 100 mmHg at screening or diastolic BP of less than 60 mmHg at screening;

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

8. 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);

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

10. History of significant allergic reaction to any drug;

11. Blood donation within 3 months of screening or plans to donate blood within 28 days of study completion;

12. Plasma donation within 7 days prior to the first dose of the study;

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

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

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

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

17. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb) at screening; or

18. Screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• COR388
Administered as oral capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cortexyme Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	Area under the plasma concentration vs. time curve (AUC) from time 0 to t.	72 hours
Primary	AUC0-inf	AUC from time 0 to infinity.	72 hours
Primary	Cmax	Maximum plasma concentration.	72 hours
Primary	Tmax	Time to Cmax.	72 hours