Study of COR388 HCl in Healthy Subjects

NCT03331900 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: COR388-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration curve (AUC)

  Analysis of AUC

  72 hours

• Maximum observed plasma concentration (Cmax)

  Analysis of Cmax

  72 hours

• Time of the first occurrence of the maximum observed plasma concentration (Tmax)

  Analysis of Tmax

  72 hours

Secondary Outcomes (4)

• Incidence of treatment emergent adverse events

  72 Hours

• Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin).

  72 hours

• Changes in hematology lab measures (RBC, Hgb, Hct).

  72 hours

• Changes in urinalysis lab parameters (pH, specific gravity, glucose).

  72 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

COR388 TBD mg

ACTIVE COMPARATOR

Drug: COR388

Interventions

COR388 DRUG

Administered as oral capsule

COR388 TBD mg

Placebo DRUG

Administered as oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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;
• Body mass index (BMI) ≥19 to ≤32 kg/m2;
• 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;
• Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study;
• Able to understand and willing to comply with all study requirements, and follow the study medication regimen.

You may not qualify if:

• 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;
• Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential);
• 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);
• Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study;
• History of significant allergic reaction to any drug;
• Participation in another investigational new drug research study within the 30 days prior to the first dose of the study;
• History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator;
• Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.

Sponsors & Collaborators

• Cortexyme Inc.: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Interventions

COR388

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 6, 2017
• Study Start: December 11, 2017
• Primary Completion: February 20, 2018
• Study Completion: April 2, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

US (1)