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
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.
Exclusion Criteria:
Single and Multiple Dose EDG-7500
Drug: EDG-7500
Single and Multiple Dose EDG-7500
Drug: EDG-7500
Single and Multiple Dose EDG-7500
Drug: EDG-7500
Solid oral formulation of EDG-7500
AUC0-last
Area under the plasma concentration time-curve from time zero to the last measured concentration
Time frame: Day 1 to Day 13
AUC0-inf
Area under the plasma concentration time-curve from time zero extrapolated to infinity
Time frame: Day 1 to Day 13
AUCtau
Area under the concentration-time curve during the dosing interval
Time frame: Day 1 to Day 13
Cmax
Maximum plasma concentration observed
Time frame: Day 1 to Day 13
Cmax,ss
Maximum plasma concentration at steady state determined directly from the concentration-time profile
Time frame: Day 1 to Day 13
Safety - TEAEs
Incidence of treatment-emergent adverse events
Time frame: Up to 23 days of monitoring
Tmax
Time to maximum plasma concentration
Time frame: Day 1 to Day 13
AUC%extrap
Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast)
Time frame: Day 1 to Day 13
CL/F
Total body clearance
Time frame: Day 1 to Day 13
Vz/F
Apparent volume of distribution
Time frame: Day 1 to Day 13
T1/2
Terminal elimination half-life
Time frame: Day 1 to Day 13
Ctrough,ss
Trough plasma concentration at steady state
Time frame: Day 1 to Day 13
Cavg,ss
Average plasma drug concentration during a dosing interval at steady state
Time frame: Day 1 to Day 13
RA(AUCtau)
Accumulation ratio for the area under the concentration-time curve during the dosing interval
Time frame: Day 1 to Day 13
RA(Cmax)
Accumulation ratio at the maximum concentration
Time frame: Day 1 to Day 13
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Edgewise Therapeutics, Inc.