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
Edgewise Therapeutics, Inc.
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- 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-…
Interventions
- DrugEDG-7500
Solid oral formulation of EDG-7500
Location
- ParexelGlendale, California