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

• Status: Not yet recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical study is to assess pharmacokinetic interactions between ethanol (EtOH) and PT150 (900 mg qd) in non-treatment-seeking alcohol-experienced volunteers-(to include military service members, veterans and/or civilians).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pop Test Oncology LLC
• Collaborators: Baylor College of Medicine; Congressionally Directed Medical Research Programs; Michael Debakey Veterans Affairs Medical Center; Michael E. DeBakey VA Medical Center; Pharmacotherapies for Alcohol and Substance Abuse Consortium
• Treatments: Ethanol

Criteria

Inclusion Criteria:

1. Provide signed and dated informed consent form;

2. Male or female, aged 21-64;

3. Must score < 10 on the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) assessed in the context of a BAL ≤ 0.00% to demonstrate that they do not need medical detoxification;

4. Must have blood lab test results within the acceptable limits noted in the protocol (Tests may be repeated if initial results are out of range);

5. Have normal vitals (heart rate 50-100 bpm, systolic blood pressure 90-140 mmHg and diastolic blood pressure 60-90 mmHg) and a baseline ECG that demonstrates clinically normal sinus rhythm, clinically normal conduction, normal QTc, and no clinically significant arrhythmias;

6. Have a self-reported medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician;

7. Must be willing to comply with all study procedures and be available for the duration of the study;

8. Women must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or using non-hormonal, medically acceptable contraception during the study and for at least 2 weeks after study completion, with or without additional hormonal contraception. Women can be receiving hormone replacement treatment (HRT) as long as the HRT dose has been stable for a period of at least 3 months;

9. Women must provide a negative urine pregnancy test within 30 days of alcohol administration on Day 1/baseline (i.e. during the screening period) and a negative serum pregnancy test on day 1 prior to alcohol administration and on day 5. Note that because participants are supervised 24-hours a day when they reside as inpatients, a urine pregnancy test is planned on day 7;

10. Able to provide proof of age and identity (includes providing full name and date of birth).

Exclusion Criteria:

1. DSM-5 criteria for substance use disorders other than alcohol or nicotine or test positive for prescription or illegal substances. With regard to marijuana/THC, an individual must test negative at intake (Day 1/baseline). If an individual tests positive, they will be given a grace period where they will have the opportunity to return and test negative prior to being enrolled;

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 birth control pills) 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;

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 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 diabetes.