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Study of COR388 HCl in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331900
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Cortexyme Inc.

Tracking Information
First Submitted Date  ICMJE October 23, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date April 18, 2018
Actual Study Start Date  ICMJE December 11, 2017
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
  • Area under the plasma concentration curve (AUC) [ Time Frame: 72 hours ]
    Analysis of AUC
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 72 hours ]
    Analysis of Cmax
  • Time of the first occurrence of the maximum observed plasma concentration (Tmax) [ Time Frame: 72 hours ]
    Analysis of Tmax
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03331900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2017)
  • Incidence of treatment emergent adverse events [ Time Frame: 72 Hours ]
    Assessment of the incidence and severity of treatment-emergent adverse events.
  • Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin). [ Time Frame: 72 hours ]
    Assessment of changes in serum chemistry measures.
  • Changes in hematology lab measures (RBC, Hgb, Hct). [ Time Frame: 72 hours ]
    Assessment of changes in hematology measures.
  • Changes in urinalysis lab parameters (pH, specific gravity, glucose). [ Time Frame: 72 hours ]
    Assessment of changes in urinalysis parameters.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of COR388 HCl in Healthy Subjects
Official Title  ICMJE A Phase 1 Single Ascending Dose Study of COR388 HCl
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: COR388
    Administered as oral capsule
  • Drug: Placebo
    Administered as oral capsule
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: COR388 TBD mg
    Intervention: Drug: COR388
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2017)
40
Actual Study Completion Date  ICMJE April 2, 2018
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331900
Other Study ID Numbers  ICMJE COR388-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cortexyme Inc.
Study Sponsor  ICMJE Cortexyme Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cortexyme Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP