A Study of EDG-7500 in Healthy Adults

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011317
• Other study ID #: EDG-7500-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 14, 2023
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Edgewise Therapeutics, Inc.
• Contact: Edgewise Therapeutics
• Phone: 720-262-7002
• Email: cardiacstudies[@]edgewisetx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• EDG-7500
EDG-7500 is administered orally once daily
• Placebo
Placebo is administered orally once daily

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Edgewise Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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