A Study of EDG-15400 in Healthy Adults

Edgewise Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adults

Treatments: Drug: EDG-15400; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07177066

EDG-15400-101

Details and patient eligibility

About

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

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

Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.

Enrollment: 108 estimated 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) ≥18.5 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 QTc interval corrected for heart rate using the Fridericia method (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 within the last 2 years.
8. Alcohol consumption > 14 drinks per week for males (7 for females) within 45 days of screening.
9. Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.

Additional protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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108 participants in 3 patient groups

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

Experimental group

Description:

Single oral ascending dose in fasted healthy adults

Treatment:

Drug: Placebo

Drug: EDG-15400

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

Experimental group

Description:

Multiple oral ascending doses once daily in fasted healthy adults

Treatment:

Drug: Placebo

Drug: EDG-15400

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

Experimental group

Description:

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

Treatment:

Drug: EDG-15400