A Study of EDG-7500 in Healthy Adults

Edgewise Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: EDG-7500; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06011317

EDG-7500-101

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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84 participants in 3 patient groups

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

Experimental group

Description:

Single oral ascending dose in healthy volunteers ages ≥ 18 to \< 60 years

Treatment:

Drug: Placebo

Drug: EDG-7500

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

Experimental group

Description:

Multiple oral ascending doses in healthy volunteers ages ≥ 18 to \< 60 years

Treatment:

Drug: Placebo

Drug: EDG-7500

Part D: Healthy Volunteer Food Effect and Relative Bioavailability

Experimental group

Description:

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

Treatment:

Drug: EDG-7500