MedTrace Logo

A Study of EDG-7500 in Healthy Adults

NCT06011317 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

EDG-7500

EDG-7500 is administered orally once daily

DRUG

Placebo

Placebo is administered orally once daily

Sponsors & Collaborators

  • Edgewise Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Edgewise Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-14
Primary Completion
2024-05-23
Completion
2024-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011317 on ClinicalTrials.gov