Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Single and Multiple Ascending Dose Study of COR588

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04920903
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Cortexyme Inc.

Brief Summary:
The study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety and tolerability of COR588 HCl in healthy male and female subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: COR588 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Oral COR588 in Healthy Adult Subjects
Actual Study Start Date : August 26, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Experimental: COR588 Drug: COR588
Increasing doses of COR588 will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.

Placebo Comparator: Placebo Drug: Placebo
Placebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events. [ Time Frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. ]
    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: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. ]
    Assessment of changes in serum chemistry measures.

  3. Changes in hematology lab measures (red blood cell count [RBC], hemoglobin [Hgb], hematocrit [Hct]). [ Time Frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. ]
    Assessment of changes in hematology measures.

  4. Changes in urinalysis lab parameters (pH, specific gravity, glucose). [ Time Frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase. ]
    Assessment of changes in urinalysis parameters.


Secondary Outcome Measures :
  1. AUC [ Time Frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase. ]
    Area under the concentration-time curve

  2. Cmax [ Time Frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase. ]
    Maximum observed drug concentration during a dosing interval

  3. Tmax [ Time Frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase. ]
    Time to Cmax



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Healthy male and female subjects between 18 to 55 years of age, inclusive (at the time of consent) for Part A;
  • Body mass index between 18 and 32 kg/m2, inclusive, at screening and Day -1;
  • Participants with no clinically significant abnormal screening results in the opinion of the investigator;
  • All screening laboratory parameters (chemistry, hematology, coagulation, urinalysis) within normal limits or considered not clinically significant in the opinion of the investigator. If necessary, in the investigator's opinion, screening labs may be repeated once to confirm the results if error is suspected.
  • Women of childbearing potential (WOCBP) must have a negative blood or urine pregnancy test within 24 hours prior to the start of investigational product and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP must agree to use an acceptable form of contraception during the treatment period and for at least 30 days after the last dose of investigational product.
  • A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 90 days after the last dose of study treatment and refrains from donating sperm during this period;
  • Agree to comply with study-specified diet and consume the high-fat breakfast in its entirety (food effect cohort) while confined in the study site;
  • Provide signed informed consent prior to any study procedures commencing, understand and comply with the requirements of the study, and be able to communicate with the investigator.

Exclusion Criteria:

  • Presence of significant neurological, cardiovascular, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease;
  • History or presence of malignancy within the past 2 years prior to Day -1 with the exception of adequately treated basal cell or squamous cell carcinoma of the skin;
  • History of conditions (e.g., chronic diarrhea or prior abdominal surgery) known to interfere with the absorption, distribution, metabolism, or excretion of drugs;
  • Clinically significant acute illness or infection within 14 days prior to Day -1;
  • Any surgical procedure within 3 months prior to Day -1, that may interfere with the performance in the study in the judgment of the investigator;
  • History or presence of cardiac abnormalities or congenital long QT syndrome;
  • Subjects with a QTcF interval >450 msec for males and >470 msec for females at screening or Day -1;
  • Any dietary restriction, intolerance, or food allergy that would prohibit the consumption of a high fat breakfast (food effect cohort only);

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): NCT04920903


Contacts
Layout table for location contacts
Contact: Joanna Bolger, MS 1-858-248-5124 jbolger@cortexyme.com
Contact: Vladimir Skljarevski, MD 1-317-985-2428 vskljarevski@cortexyme.com

Locations
Layout table for location information
Australia, Victoria
Nucleus Network Pty Ltd Recruiting
Melbourne, Victoria, Australia
Contact: Philip Ryan, MD    0438009787    p.ryan@nucleusnetwork.com.au   
Sponsors and Collaborators
Cortexyme Inc.
Layout table for additonal information
Responsible Party: Cortexyme Inc.
ClinicalTrials.gov Identifier: NCT04920903    
Other Study ID Numbers: COR588
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes