A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers (EDG-5506-102)

Edgewise Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Verapamil; Drug: sevasemten

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916897

EdgewiseTX

Details and patient eligibility

About

The purposes of this Phase 1 study of sevasemten are to:

1. Evaluate the effect of multiple-dose administration of verapamil on the single-dose of sevasemten in healthy adults
2. Evaluate the safety and tolerability of a single dose of sevasemten administered with and without verapamil in healthy adult subjects.
3. Evaluate the safety and tolerability of a single dose of sevasemten administered with and without food in healthy adult subjects.

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy, adult, male or female (of non-childbearing potential)18-60 years of age, inclusive, at the screening visit.
2. Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting.
3. Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2 at the screening visit.
4. Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs.
5. Willing and able to comply with the protocol.

Exclusion criteria

1. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
2. History or presence of alcohol or drug abuse (except for use of cannabis products) within the past 2 years prior to first dosing.
3. Female subjects of childbearing potential.
4. Alcohol consumption > 14 drinks per week for males or ˃ 7 drinks for females within 45 days prior to the screening visit.
5. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
6. Any drugs known to be moderate or strong inducers of CYP3A4 enzymes/or P glycoprotein, including St. John's Wort, beginning 28 days prior to the first dosing.
7. Is lactose intolerant.
8. Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to first dosing, whichever is longer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Treatment A: single dose sevasemten

Experimental group

Description:

Single dose sevasemten administered on Day 1 under fasting conditions

Treatment:

Drug: sevasemten

Treatment B: multiple doses of verapamil and single dose of sevasemten

Experimental group

Description:

Multiple doses of verapamil with a single dose of sevasemten under fasting conditions

Treatment:

Drug: sevasemten

Drug: Verapamil

Treatment C: single dose sevasemten and high-fat meal

Experimental group

Description:

Single dose sevasemten under high-fat fed conditions

Treatment:

Drug: sevasemten