Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Edgewise Therapeutics, Inc.
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers
