drugset / Trial / NCT06011317

A Study of EDG-7500 in Healthy Adults

NCT06011317 ↗

Phase 1 Completed 84 enrolled Edgewise Therapeutics, Inc.
RandomizedSequentialTriple-blindTreatment

Summary

The purposes of this Phase 1 study of EDG-7500 are to: 1. Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults 2. Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy adults 3. Evaluate the amount of EDG-7500 is 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-7500 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-7500 in the blood is similar for the suspension and tablet forms of EDG-7500 in healthy adults Participants will receive a single or multiple doses of EDG-7500 or a placebo by mouth.

Timeline

Start
2023-08-14
Primary completion
2024-05-23
Completion
2024-06-20

Outcome

Met primary endpoint

release “Announced positive top-line data from Phase 1 trial in healthy subjects and Phase 2 CIRRUS-HCM trial in patients with obstructive HCM” edgewisetx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject EDG-7500 Unknown — Oral

Indications

No indication recorded.