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NCT Number: NCT07456059

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

EDG-7500

Drug

Solid oral formulation of EDG-7500

Primary outcomes

  1. AUC0-last

    Time frame: Day 1 to Day 13

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

  2. AUC0-inf

    Time frame: Day 1 to Day 13

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

  3. AUCtau

    Time frame: Day 1 to Day 13

    Area under the concentration-time curve during the dosing interval

  4. Cmax

    Time frame: Day 1 to Day 13

    Maximum plasma concentration observed

  5. Cmax,ss

    Time frame: Day 1 to Day 13

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

Secondary outcomes

  1. Safety - TEAEs

    Time frame: Up to 23 days of monitoring

    Incidence of treatment-emergent adverse events

  2. Tmax

    Time frame: Day 1 to Day 13

    Time to maximum plasma concentration

  3. AUC%extrap

    Time frame: Day 1 to Day 13

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

  4. CL/F

    Time frame: Day 1 to Day 13

    Total body clearance

  5. Vz/F

    Time frame: Day 1 to Day 13

    Apparent volume of distribution

  6. T1/2

    Time frame: Day 1 to Day 13

    Terminal elimination half-life

  7. Ctrough,ss

    Time frame: Day 1 to Day 13

    Trough plasma concentration at steady state

  8. Cavg,ss

    Time frame: Day 1 to Day 13

    Average plasma drug concentration during a dosing interval at steady state

  9. RA(AUCtau)

    Time frame: Day 1 to Day 13

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

  10. RA(Cmax)

    Time frame: Day 1 to Day 13

    Accumulation ratio at the maximum concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Edgewise Therapeutics, Inc.

CONTACT

[email protected]

720-262-7002

Sponsors and collaborators

Lead sponsor

Edgewise Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1, Single-center, Open-label, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Dose and Multiple Doses of EDG-7500 in Healthy Adult Caucasian and Japanese Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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