Study of COR388 HCl in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

A Phase 1 Single Ascending Dose Study of COR388 HCl

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331900
• Other study ID #: COR388-001
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Subjects

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