A Study of Atorvo+™ in Healthy Adult Participants

Exclusion Criteria

• •12. Male participants must be willing not to donate sperm throughout the study and for 93 days (90 days + approximately 5 half-lives) after the last dose of IP.
• •13. Willing and able to adhere to all study requirements, including willingness to remain in the study unit for the entire duration of the confinement period.
• •14. Participant has a good venous access bilaterally.
• •1. History of any clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine (including type 2 diabetes), oncologic, pulmonary, immunologic, or cardiovascular disease or other condition which could jeopardize safety or impact validity of results at the discretion of the PI.
• •2. Has any documented clinically significant infection, injury, or illness within 1 month prior to Screening.
• •3. Has any documented history of, or currently active, seizure disorder or history of clinically significant head injury.
• •4. Has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin).
• •5. Any laboratory test results deemed clinically significant by the PI (clinically significant results may be repeated once at discretion of the investigator) or positive test for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
• •6. Positive COVID-19 polymerase chain reaction (PCR) test results at Day -1.
• •7. History of inherent cardiac abnormalities at the discretion of the PI.
• •8. Clinically significant ECG abnormalities (Fridericia's corrected QT interval \[QTcF\] \>450 msec for males and \>470 msec for females), PR \>210 msec, QRS interval \>120 msec at Screening (clinically significant results may be repeated once at discretion of the investigator).
• •9. ALT, AST, total cholesterol, LDL-C, or triglycerides \>1.5 × the upper limit of normal (ULN) at Screening. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designees.
• •10. Known allergic reactions to any excipient in the IP formulations.
• •11. History of significant drug abuse such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to Screening.
• •12. Use of marijuana or THC (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
• •13. Positive screen for urine drug, urine cotinine (Day -1 only), or breath alcohol test at Screening or Day -1 (positive results may be repeated once at discretion of the investigator).
• •14. History of significant alcohol abuse within 1 year prior to Screening or regular use of alcohol within 6 months prior to Screening that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of 40% distilled alcohol).
• •15. Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety (eg, topical drug products without significant systemic absorption):
• •1. Prescription medications (except for contraceptives) within 14 days prior to the first dose until end of the study;
• •2. Monoamine oxidase inhibitors (MAOIs) within 28 days prior to dosing and during the study;
• •3. Over-the-counter products and natural health products (including herbal remedies such as St. John's wort, homeopathic and traditional medicines), and antacid preparations within 14 days prior to the first dose up to end of study. Vitamins used as nutritional supplements in non-therapeutic doses may be accepted at the discretion of the PI or designee, but they must be stopped at least 48 hours before dosing and during the study.
• •4. Any drugs known to induce or inhibit hepatic and renal drug metabolism within 30 days prior to the first dose and during the study.
• •5. Any known CYP2C9 and CYP3A4 enzymes altering drugs (eg, amiodarone, fluconazole, ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, etc.) within 28 days prior to the first dose and during the study.
• •6. Any drug that has a significant impact on the central nervous system (CNS) including benzodiazepines (eg, diazepam, alprazolam, lorazepam), antipsychotic medications (eg, haloperidol, risperidone, quetiapine), antidepressants (eg, sertraline, fluoxetine, escitalopram), antiepileptic drugs (eg, phenytoin, carbamazepine, valproate) or sedative-hypnotics (eg, zolpidem, zopiclone, eszopiclone) within 30 days prior to the first dose and during the study.
• •7. Any BP regularizing drugs including antihypertensive agents (eg, amlodipine, lisinopril, metoprolol), diuretics (eg, hydrochlorothiazide, furosemide, spironolactone), vasodilators (eg, hydralazine, nitroglycerin, minoxidil), alpha-blockers (eg, doxazosin, prazosin, terazosin) within 30 days prior to the first dose and during the study.
• •16. Consumption of beverages or foods that contain grapefruit or Seville oranges, or products containing these fruits, within 7 days prior to the first dose and during the study.
• •17. Use of any investigational or marketed drug or medical device in a clinical trial within 30 days of 5 half-lives (whichever is longer) prior to the first dose of IP administration, administration of a biological product in the context of a clinical research study within 90 days prior to IP administration, or concomitant participation in an investigational study involving no drug or device administration.
• •18. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to Day -1.
• •19. Participant is unwilling to refrain from strenuous exercise (including weightlifting) from 7 days prior to admission to the site until completion of the final Follow-up visit.
• •20. Any underlying physical or psychological medical condition that, in the opinion of the PI, could confound the results of the study or make it unlikely for the participant to comply with the protocol or complete the study per protocol.
• •21. Current suicidal ideation as assessed by the C-SSRS (Baseline/Screening) up to 1 month prior to Screening; Participants with a significant psychiatric history including previous suicide attempt or a lifetime history of suicidal ideation may be excluded at the discretion of the PI or designee.
• •22. Any reason which, in the opinion of the Investigator or Sponsor, would prevent the participant from participating in the study.