Healthy Adult Participants
Conditions
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.
Interventions
DRUGEDG-7500
Solid oral formulation of EDG-7500
Sponsors
Edgewise Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-last | Day 1 to Day 13 | Area under the plasma concentration time-curve from time zero to the last measured concentration |
| AUC0-inf | Day 1 to Day 13 | Area under the plasma concentration time-curve from time zero extrapolated to infinity |
| AUCtau | Day 1 to Day 13 | Area under the concentration-time curve during the dosing interval |
| Cmax | Day 1 to Day 13 | Maximum plasma concentration observed |
| Cmax,ss | Day 1 to Day 13 | Maximum plasma concentration at steady state determined directly from the concentration-time profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - TEAEs | Up to 23 days of monitoring | Incidence of treatment-emergent adverse events |
| Tmax | Day 1 to Day 13 | Time to maximum plasma concentration |
| AUC%extrap | Day 1 to Day 13 | Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast) |
| CL/F | Day 1 to Day 13 | Total body clearance |
| Vz/F | Day 1 to Day 13 | Apparent volume of distribution |
| T1/2 | Day 1 to Day 13 | Terminal elimination half-life |
| Ctrough,ss | Day 1 to Day 13 | Trough plasma concentration at steady state |
| Cavg,ss | Day 1 to Day 13 | Average plasma drug concentration during a dosing interval at steady state |
| RA(AUCtau) | Day 1 to Day 13 | Accumulation ratio for the area under the concentration-time curve during the dosing interval |
| RA(Cmax) | Day 1 to Day 13 | Accumulation ratio at the maximum concentration |
Countries
United States
Outcome results
None listed