Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04092751
Eligibility Criteria:
Inclusion Criteria:
1. is a male or female between 18 to 55 years, inclusive, of age at the prestudy (screening) visit (time of signing the Informed Consent).
2. has a Body Mass Index (BMI) 18.0 to 32 kg/m2 at the prestudy (screening) visit.
3. is judged to be in good health based on medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug.
4. has been is a nonsmoker and/or has not used nicotine or nicotine-containing products for approximately 6 months prior to screening.
5. is willing and able to understand and provide signed informed consent and understands the study procedures and agrees to participate in the study.
6. is not pregnant or lactating (for women of childbearing potential) and must agree to use adequate double barrier birth control.
NOTE: Women of childbearing potential must have a negative serum pregnancy test (β human chorionic gonadotropin \[β-hCG\]) at Screening visit and negative urine pregnancy test at each treatment period (conducted on Day -1 prior to dosing).
Exclusion Criteria:
1. has a contra-indication to Pravachol® (pravastatin sodium).
2. has severe liver disease or chronically elevated liver enzymes.
3. is pregnant or lactating
4. has a history of uncontrolled or unstable cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematopoietic, neoplastic, and/or neurological disease.
5. has a current or recent (within 3 months) gastrointestinal (GI) disease or any GI surgery that could impact absorption of study drug.
6. has a history of any illness that, in the opinion of the investigator, could confound the results of the study or pose an additional risk to the subject by their participation in the study.
7. has a QTcF interval \>480 msec at the Screening or Day -1 visits of the study.
8. subject consumed Seville or blood oranges, grapefruit or grapefruit juice, or mulberry juice , as well as vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) and or charbroiled meats from 4 days prior to the dose of study medication.
9. has consumed any alcohol within 7 days before dosing SCY-078 prior to dose of study medication or has a history of alcohol abuse.
10. has a positive drug and or alcohol screen at screening and or (each) admission to the clinical research center.
11. is a smoker or has used tobacco or any nicotine-containing products within the 6 months prior to the first dosing in the study screening.
12. has been participated in a clinical investigation of any drug, biological, or other investigational therapy, device or procedure 30 days before dosing
13. has a history of an allergic reaction to SCY-078 or any of its excipients, or is allergic to Pravachol® (pravastatin sodium), or its inactive ingredients.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04092751
Study Brief:
Protocol Section:
NCT04092751