A Study of EDG-15400 in Healthy Adults

NCT07177066 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EDG-15400-101
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this Phase 1 study of EDG-15400 are to:

1. 1.Learn about the safety of EDG-15400 after single and multiple doses in healthy adults
2. 2.Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults
3. 3.Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults
4. 4.Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults
5. 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

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Safety: incidence of treatment-emergent adverse events

  To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults

  Up to 25 days of monitoring

Secondary Outcomes (7)

• Determination of Tmax

  Up to 25 days

• Determination of Cmax

  Up to 25 days

• Determination of AUC

  Up to 25 days

• Determination of t1/2

  Up to 25 days

• Determination of V/F

  Up to 25 days

Study Arms (3)

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

EXPERIMENTAL

Single oral ascending dose in fasted healthy adults

Drug: EDG-15400; Drug: Placebo

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

EXPERIMENTAL

Multiple oral ascending doses once daily in fasted healthy adults

Drug: EDG-15400; Drug: Placebo

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

EXPERIMENTAL

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

Drug: EDG-15400

Interventions

EDG-15400 DRUG

EDG-15400 is administered orally

Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose; Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses; Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability

Placebo DRUG

Placebo is administered orally

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

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give informed consent and follow all study procedures and requirements.
• Healthy male or nonpregnant female, ages ≥18 to \<60 years.
• Body mass index (BMI) ≥18.5 to \<35 kg/m2; weight ≥55 kg at Screening.
• 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.

You may not qualify if:

• Evidence of clinically significant abnormalities or disease.
• 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.
• Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing.
• Females: nursing, lactating, or pregnant.
• Females: breast implants.
• Use of nicotine-containing products in the last 6 months prior to dosing.
• History of substance abuse or dependency or history of recreational drug use within the last 2 years.
• Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening.
• Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

RECRUITING

Central Study Contacts

Contact: Edgewise Therapeutics, Inc.

CONTACT

720-262-7002; cardiacstudies@edgewisetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 16, 2025
• Study Start: August 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)