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Study of COR388 HCl in Healthy Subjects

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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.

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: COR388 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Phase 1 Single Ascending Dose Study of COR388 HCl
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : April 2, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Administered as oral capsule

Active Comparator: COR388 TBD mg Drug: COR388
Administered as oral capsule




Primary Outcome Measures :
  1. Area under the plasma concentration curve (AUC) [ Time Frame: 72 hours ]
    Analysis of AUC

  2. Maximum observed plasma concentration (Cmax) [ Time Frame: 72 hours ]
    Analysis of Cmax

  3. Time of the first occurrence of the maximum observed plasma concentration (Tmax) [ Time Frame: 72 hours ]
    Analysis of Tmax


Secondary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: 72 Hours ]
    Assessment of the incidence and severity of treatment-emergent adverse events.

  2. 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.

  3. Changes in hematology lab measures (RBC, Hgb, Hct). [ Time Frame: 72 hours ]
    Assessment of changes in hematology measures.

  4. Changes in urinalysis lab parameters (pH, specific gravity, glucose). [ Time Frame: 72 hours ]
    Assessment of changes in urinalysis parameters.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331900


Locations
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United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Cortexyme Inc.

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Responsible Party: Cortexyme Inc.
ClinicalTrials.gov Identifier: NCT03331900     History of Changes
Other Study ID Numbers: COR388-001
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No