Healthy Subjects
Conditions
Brief summary
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.
Interventions
DRUGsevasemten
single dose 10mg sevasemten administered orally
DRUGVerapamil
multiple doses 240mg verapamil
Sponsors
Edgewise Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic | Up to 46 days of monitoring | The area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) for sevasemten and metabolites administered with and without verapamil |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Up to 46 days of monitoring | Incidence of treatment emergent adverse events in those with a single dose of sevasemten administered with and without verapamil and with or without food |
Countries
United States
Outcome results
None listed