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CompletedNCT07456059Updated Jul 31, 2026

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

A Phase 1 interventional study of EDG-7500 in Healthy Adult Participants, sponsored by Edgewise Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Edgewise Therapeutics, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Adult Participants
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Cohort 1 - Healthy Japanese Adults

    Single and Multiple Dose EDG-7500

    Drug: EDG-7500

  • Experimental
    Cohort 2 - Healthy Japanese Adults

    Single and Multiple Dose EDG-7500

    Drug: EDG-7500

  • Experimental
    Cohort 3 - Healthy Caucasian Adults

    Single and Multiple Dose EDG-7500

    Drug: EDG-7500

Interventions

  • DrugEDG-7500

    Solid oral formulation of EDG-7500

05

What researchers measure

Primary outcomes

  1. AUC0-last

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

    Time frame: Day 1 to Day 13

  2. AUC0-inf

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

    Time frame: Day 1 to Day 13

  3. AUCtau

    Area under the concentration-time curve during the dosing interval

    Time frame: Day 1 to Day 13

  4. Cmax

    Maximum plasma concentration observed

    Time frame: Day 1 to Day 13

  5. Cmax,ss

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

    Time frame: Day 1 to Day 13

Secondary outcomes

  1. Safety - TEAEs

    Incidence of treatment-emergent adverse events

    Time frame: Up to 23 days of monitoring

  2. Tmax

    Time to maximum plasma concentration

    Time frame: Day 1 to Day 13

  3. AUC%extrap

    Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast)

    Time frame: Day 1 to Day 13

  4. CL/F

    Total body clearance

    Time frame: Day 1 to Day 13

  5. Vz/F

    Apparent volume of distribution

    Time frame: Day 1 to Day 13

  6. T1/2

    Terminal elimination half-life

    Time frame: Day 1 to Day 13

  7. Ctrough,ss

    Trough plasma concentration at steady state

    Time frame: Day 1 to Day 13

  8. Cavg,ss

    Average plasma drug concentration during a dosing interval at steady state

    Time frame: Day 1 to Day 13

  9. RA(AUCtau)

    Accumulation ratio for the area under the concentration-time curve during the dosing interval

    Time frame: Day 1 to Day 13

  10. RA(Cmax)

    Accumulation ratio at the maximum concentration

    Time frame: Day 1 to Day 13

06

Study locations

1 site
  • Parexel
    Glendale, California 91206, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07456059
Lead sponsor
Edgewise Therapeutics, Inc.
Responsible party
Sponsor
First posted
Mar 6, 2026
Start date
Mar 10, 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Jul 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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