A Study of EDG-15400 in Healthy Adults

NCT ID: NCT07177066

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-05-31

Brief Summary

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose

Single oral ascending dose in fasted healthy adults

Group Type: EXPERIMENTAL

EDG-15400

Intervention Type: DRUG

EDG-15400 is administered orally

Placebo

Intervention Type: DRUG

Placebo is administered orally

Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses

Multiple oral ascending doses once daily in fasted healthy adults

Group Type: EXPERIMENTAL

EDG-15400

Intervention Type: DRUG

EDG-15400 is administered orally

Placebo

Intervention Type: DRUG

Placebo is administered orally

Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability

Crossover food effect (fed versus fasted) single oral dose in healthy adults and relative bioavailability of liquid versus solid formulation

Group Type: EXPERIMENTAL

EDG-15400

Intervention Type: DRUG

EDG-15400 is administered orally

Interventions

EDG-15400

EDG-15400 is administered orally

Intervention Type: DRUG

Placebo

Placebo is administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Edgewise Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion, Inc.

Tempe, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Contact: Edgewise Therapeutics, Inc.

Role: CONTACT

cardiacstudies@edgewisetx.com

720-262-7002

Facility Contacts

Edgewise Therapeutics, Inc.

Role: primary

720-262-7002

Other Identifiers

EDG-15400-101

Identifier Type: -

Identifier Source: org_study_id