RECRUITING

A Study of EDG-15400 in Healthy Adults

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-20

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07177066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Willing and able to give informed consent and follow all study procedures and requirements. 2. Healthy male or nonpregnant female, ages ≥18 to \<60 years. 3. Body mass index (BMI) ≥18.5 to \<35 kg/m2; weight ≥55 kg at Screening. 4. Absence of important health problems and essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTc interval corrected for heart rate using the Fridericia method (QTcF) ≤450 ms.	1. Evidence of clinically significant abnormalities or disease. 2. Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5 days prior to dosing. 3. Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing. 4. Females: nursing, lactating, or pregnant. 5. Females: breast implants. 6. Use of nicotine-containing products in the last 6 months prior to dosing. 7. History of substance abuse or dependency or history of recreational drug use within the last 2 years. 8. Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening. 9. Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.

Inclusion Criteria

Exclusion Criteria

1. Willing and able to give informed consent and follow all study procedures and requirements.
2. Healthy male or nonpregnant female, ages ≥18 to \<60 years.
3. Body mass index (BMI) ≥18.5 to \<35 kg/m2; weight ≥55 kg at Screening.
4. Absence of important health problems and essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTc interval corrected for heart rate using the Fridericia method (QTcF) ≤450 ms.

1. Evidence of clinically significant abnormalities or disease.
2. Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5 days prior to dosing.
3. Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing.
4. Females: nursing, lactating, or pregnant.
5. Females: breast implants.
6. Use of nicotine-containing products in the last 6 months prior to dosing.
7. History of substance abuse or dependency or history of recreational drug use within the last 2 years.
8. Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening.
9. Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.

Contacts and Locations

Study Contact

Contact: Edgewise Therapeutics, Inc.

CONTACT

720-262-7002

cardiacstudies@edgewisetx.com

Study Locations (Sites)

Celerion, Inc.

Tempe, Arizona, 85283

United States

Collaborators and Investigators

Sponsor: Edgewise Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-20

Study Completion Date2026-05

Study Record Updates

Study Start Date2025-08-20

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Healthy Adults