Celerion, Inc.
Tempe, Arizona, 85283, United States
NCT Number: NCT07177066
The purposes of this Phase 1 study of EDG-15400 are to:
1. Learn about the safety of EDG-15400 after single and multiple doses in healthy adults 2. Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults 3. Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults 4. Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-15400 in the blood is similar for the suspension and tablet forms of EDG-15400 in healthy adults
Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.
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Notify Me18 year–59 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional protocol defined inclusion/exclusion criteria may apply.
EDG-15400 is administered orally
Placebo is administered orally
Time frame: Up to 45 days of monitoring
To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults
Time frame: Up to 38 days
Time to maximum concentration (Tmax)
Time frame: Up to 38 days
Maximum observed concentration (Cmax)
Time frame: Up to 38 days
Area under the concentration-time curve (AUC)
Time frame: Up to 38 days
Elimination half-life (t1/2)
Time frame: Up to 38 days
Apparent volume of distribution after oral administration (V/F)
Time frame: Up to 38 days
Apparent clearance of drug after oral administration (CL/F)
Time frame: Up to 38 days
Renal clearance (CLr)
Edgewise Therapeutics, Inc.
Industry
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Healthy Adults
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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