Parexel
Glendale, California, 91206, United States
NCT Number: NCT07456059
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Solid oral formulation of EDG-7500
Time frame: Day 1 to Day 13
Area under the plasma concentration time-curve from time zero to the last measured concentration
Time frame: Day 1 to Day 13
Area under the plasma concentration time-curve from time zero extrapolated to infinity
Time frame: Day 1 to Day 13
Area under the concentration-time curve during the dosing interval
Time frame: Day 1 to Day 13
Maximum plasma concentration observed
Time frame: Day 1 to Day 13
Maximum plasma concentration at steady state determined directly from the concentration-time profile
Time frame: Up to 23 days of monitoring
Incidence of treatment-emergent adverse events
Time frame: Day 1 to Day 13
Time to maximum plasma concentration
Time frame: Day 1 to Day 13
Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast)
Time frame: Day 1 to Day 13
Total body clearance
Time frame: Day 1 to Day 13
Apparent volume of distribution
Time frame: Day 1 to Day 13
Terminal elimination half-life
Time frame: Day 1 to Day 13
Trough plasma concentration at steady state
Time frame: Day 1 to Day 13
Average plasma drug concentration during a dosing interval at steady state
Time frame: Day 1 to Day 13
Accumulation ratio for the area under the concentration-time curve during the dosing interval
Time frame: Day 1 to Day 13
Accumulation ratio at the maximum concentration
Edgewise Therapeutics, Inc.
Industry
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
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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