A Study of EDG-7500 in Healthy Adults

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Healthy Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: EDG-7500; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Edgewise Therapeutics; Phone Number: 720-262-7002; Email: cardiacstudies@edgewisetx.com

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Recruiting
      • Celerion
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Active, not recruiting
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 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 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. Alcohol consumption > 14 drinks per week for males (7 for females). Positive screen for drugs of abuse or alcohol or cotinine test at Screening or Admission.

Additional protocol defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose; Single oral ascending dose in healthy volunteers ages ≥ 18 to < 60 years	Drug: EDG-7500; EDG-7500 is administered orally once daily; Drug: Placebo; Placebo is administered orally once daily
Experimental: Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses; Multiple oral ascending doses in healthy volunteers ages ≥ 18 to < 60 years	Drug: EDG-7500; EDG-7500 is administered orally once daily; Drug: Placebo; Placebo is administered orally once daily
Experimental: Part D: Healthy Volunteer Food Effect and Relative Bioavailability; Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation	Drug: EDG-7500; EDG-7500 is administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: incidence of treatment-emergent adverse events	To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses	Up to 25 days of monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of pharmacokinetics parameters as measured by Tmax	Time to maximum concentration (Tmax)	Up to 25 days of monitoring
Determination of pharmacokinetic parameters as measured by Cmax	Maximum observed concentration (Cmax)	Up to 25 days of monitoring
Determination of pharmacokinetic parameters as measured by AUC	Area under the concentration-time curve (AUC)	Up to 25 days of monitoring
Determination of pharmacokinetic parameters as measured by t1/2	Terminal half-life (t1/2)	Up to 25 days of monitoring
Determination of renal clearance as measured by CLr	Renal clearance (CLr)	Up to 25 days of monitoring

Collaborators and Investigators

• Sponsor: Edgewise Therapeutics, Inc.
• Investigators: Study Director: Medical Director, Edgewise Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 13, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EDG-7500-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No