A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults

NCT07456059 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: EDG-7500-107
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (5)

• AUC0-last

  Area under the plasma concentration time-curve from time zero to the last measured concentration

  Day 1 to Day 13

• AUC0-inf

  Area under the plasma concentration time-curve from time zero extrapolated to infinity

  Day 1 to Day 13

• AUCtau

  Area under the concentration-time curve during the dosing interval

  Day 1 to Day 13

• Cmax

  Maximum plasma concentration observed

  Day 1 to Day 13

• Cmax,ss

  Maximum plasma concentration at steady state determined directly from the concentration-time profile

  Day 1 to Day 13

Secondary Outcomes (10)

• Safety - TEAEs

  Up to 23 days of monitoring

• Tmax

  Day 1 to Day 13

• AUC%extrap

  Day 1 to Day 13

• CL/F

  Day 1 to Day 13

• Vz/F

  Day 1 to Day 13

Study Arms (3)

Cohort 1 - Healthy Japanese Adults

EXPERIMENTAL

Single and Multiple Dose EDG-7500

Drug: EDG-7500

Cohort 2 - Healthy Japanese Adults

EXPERIMENTAL

Single and Multiple Dose EDG-7500

Drug: EDG-7500

Cohort 3 - Healthy Caucasian Adults

EXPERIMENTAL

Single and Multiple Dose EDG-7500

Drug: EDG-7500

Interventions

EDG-7500 DRUG

Solid oral formulation of EDG-7500

Cohort 1 - Healthy Japanese Adults; Cohort 2 - Healthy Japanese Adults; Cohort 3 - Healthy Caucasian Adults

Eligibility Criteria

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

You may qualify if:

• Adult, male or female, 18-55 years of age, inclusive.
• Medically healthy based on a medical evaluation (including medical history, physical examination, vital signs measurement, 12-lead ECG, and clinical laboratory evaluations) performed at screening.
• Meets the protocol-specified criteria to qualify as a Japanese or Caucasian participant.
• BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.
• Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and \<140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.
• eGFR ≥ 80 mL/min/1.73 m2 calculated using the CKD-EPI formula at screening.
• Female and male participants must follow protocol-specified contraception guidance.

You may not qualify if:

• History or evidence of any clinically significant cardiovascular, dermatologic, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, respiratory, and/or other major disorders or malignancy.
• History or evidence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV).
• History of significant blood loss, donation of blood, or received a transfusion of any blood or blood products within 60 days prior to screening.
• History of plasma donation within 7 days prior to screening.
• History of use of tobacco- or nicotine-containing products within six months prior to screening.
• Participating in another interventional clinical study or has used an investigational drug within 30 days or 5 half-lives prior to screening.
• History of alcohol and/or illicit drug abuse within 2 years of study participation.
• Positive urine test for alcohol or a positive urine drug test at screening or check-in.
• Breastfeeding or has a positive serum pregnancy test at screening or check-in.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (1)

Parexel

Glendale, California, 91206, United States

Location

Central Study Contacts

Edgewise Therapeutics, Inc.

CONTACT

720-262-7002; cardiacstudies@edgewisetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)