Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)

Exclusion Criteria

• •1. DSM-5 criteria for substance use disorders other than alcohol, nicotine, or marijuana or test positive for prescription or illegal substances other than THC. With regard to marijuana/THC, an individual must agree to abstain from marijuana/THC use three days prior to intake (Day 1/baseline);
• •2. Be pregnant or nursing;
• •3. Be receiving HRT where their dose has not been stable for a minimum of 3 months;
• •4. To reduce variability in the magnitude of drug-drug interactions (DDIs), use of concomitant medications (except hormonal birth control) or OTC medications should be excluded for a sufficient time before subject enrollment (at least 14 days or 5 half-lives \[whichever is longer\]) and for the entire duration of the study. These items should be excluded for a longer time period if the DDI mechanism is induction or time-dependent inhibition. Concomitant medication use includes any prescription, over-the-counter medications or dietary/herbal/nutritional supplements;
• •5. Be receiving any non-pharmacotherapy treatments or procedures for which there are precautions for taking concomitantly with PT150 and/or those that might interfere with the study;
• •6. Have neurological or psychiatric disorders other than AUD or SUD for THC;
• •7. History of suicide attempts and/or current suicidal ideation/plan;
• •8. Have evidence of untreated or unstable medical illness including: cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active HIV+, AIDS infection;
• •9. Have a history of medically adverse reactions to alcohol (e.g., loss of consciousness (LOC), chest pain, or epileptic seizure) or major alcohol-related medical complications requiring hospitalization (i.e. hepatitis or pancreatitis);
• •10. Have contraindication(s) to take the study medications such as renal or hepatic impairment, congenital metabolic disorders, or hypersensitivity to study medication class (i.e., glucocorticoid antagonists);
• •11. Have past brain injury/head trauma with current symptoms (e.g. not photophobic, dizziness, etc.) or past report of LOC for \>30 minutes and/or have been blast-exposed or had LOC of \>1 minute within the last 10 years and current post-concussive symptoms;
• •12. Self-report more than thirty days' abstinence from alcohol during the three months prior to enrollment/consent;
• •13. Current signs of violence or aggression assessed as part of the consent process;
• •14. Participation in a pharmaceutical trial or exposure to investigational drugs within 1 month of the screening visit;
• •15. Be currently seeking treatment for AUD;
• •16. Have any other illness, condition, or use medications (psychotropic or antiretroviral), which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study;
• •17. A history of adrenal insufficiency or a baseline plasma cortisol level of ≤ 5mcg/dL;
• •18. A baseline cortisol of \> 5 mcg/dL BUT a post-ACTH stimulation cortisol of \<18 mcg/dL;
• •19. Have been treated with any form of corticosteroid in the past 30 days;
• •20. Have a history of endometrial hyperplasia, endometrial cancer, uterine polyps, or unexplained vaginal bleeding;
• •21. Have potassium levels below the normal reference range;
• •22. Men taking testosterone replacement therapy;
• •23. Men or women currently interested in fertility;
• •24. Have underlying inflammatory or auto-immune disorders;
• •25. Have elevated thyroid stimulating hormone (TSH) levels;
• •26. Have Type I diabetes.