A Study of EDG-7500 in Healthy Adults

• Sponsor: Edgewise Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06011317
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: EDG-7500; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

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 C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses Multiple oral ascending doses in healthy volunteers ages ≥ 60 to ≤ 72 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

Outcome Measures

Primary Outcome Measures

1. Safety: incidence of treatment-emergent adverse events [Up to 25 days of monitoring]

   To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses

Secondary Outcome Measures

1. Determination of pharmacokinetics parameters as measured by Tmax [Up to 25 days of monitoring]

   Time to maximum concentration (Tmax)

2. Determination of pharmacokinetic parameters as measured by Cmax [Up to 25 days of monitoring]

   Maximum observed concentration (Cmax)

3. Determination of pharmacokinetic parameters as measured by AUC [Up to 25 days of monitoring]

   Area under the concentration-time curve (AUC)

4. Determination of pharmacokinetic parameters as measured by t1/2 [Up to 25 days of monitoring]

   Terminal half-life (t1/2)

5. Determination of renal clearance as measured by CLr [Up to 25 days of monitoring]

   Renal clearance (CLr)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 72 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 ≤ 72 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• Edgewise Therapeutics, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Edgewise Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT06011317
• Other Study ID Numbers: EDG-7500-101
• First Posted: Aug 25, 2023
• Last Update Posted: Aug 29, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 29, 2023