Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

• Status: Completed
• Trial end date: 2019-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the clinical study is to compare pharmacodynamic and safety endpoints following an alcohol challenge prior to and concurrent with PT150 (study drug) treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria: - Provide signed and dated informed consent;

• male and female, ages 21 to 64;

• must score <10 on the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) assessed in the context of a blood alcohol level (BAL) ≤ 0.02% to demonstrate that they do not need medical detoxification; must have blood laboratory test results within acceptable limits (normal range as noted per protocol);

• have normal vitals (heart rate 60-100 beats per minute (bpm), systolic blood pressure 90-140 millimeter of mercury (mmHg) and diastolic blood pressure 60-90 mmHg); a baseline electrocardiogram (ECG) that demonstrates clinically normal sinus rhythm, clinically normal conduction, normal QTc, and no clinically significant arrhythmias;

• have a self-reported medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgement of the admitting physician;

• must be willing to comply with all study procedures and be available for the duration of the study;

• 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;

• women must provide negative urine pregnancy tests before study entry (urine), and before alcohol administrations on day 0 or 1 (serum) and on day 5 (urine);

• able to provide proof of age and identity (includes providing full name and date of birth), forms of proof as defined per protocol.

Exclusion Criteria:

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for substance use disorders other than alcohol or nicotine or test positive for prescription or illegal substances. With regard to marijuana/tetrahydrocannabinols (THC), an individual must test negative at the 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;

• pregnant or nursing;

• receiving HRT where their dose has not been stable for a minimum of 3 months;

• use of concomitant medications (except birth control pills) or other the counter (OTC) supplements for at least 14 days or 5 half-lives (whichever is longer) before the start of the study and for the entire duration of the study. Concomitant medication use includes any prescription, OTC medications, or herbal supplements;

• receiving any non-pharmacotherapy treatments or procedures for which there are precautions for taking concomitantly with PT150 and/or those that interfere with the study;

• have neurological or psychiatric disorders other than Alcohol Use Disorder (AUD);

• history of suicide attempts and/or current suicidal ideation/plan;

• have evidence of untreated or unstable medical illness including: cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active Human Immucodeficiency Virus (HIV) +, Acquired Immune Deficiency Syndrome (AIDS) infection;

• have a history of medically adverse reactions to alcohol (e.g., loss of consciousness, chest pain, or epileptic seizure) or major alcohol-related medical complications requiring hospitalization (i.e., hepatitis or pancreatitis);

• 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., glucosteroid abntagonist);

• have past brain injury/head trauma with current symptoms (e.g., not photophobic, dizziness etc.) or past report of loss of consciousness (LOC) for >30 minutes and/or have been blast-exposed or had LOC >1 minute and current post-concussive symptoms;

• self report more than thirty days' abstinence from alcohol during the three months prior to enrollment/consent;

• current signs or violence or aggression, assessed as part of the consent process;

• a history of adrenal insufficiency or a plasma cortisol level of ≤ 5 microgram per deciliter (mcg/dl) at screening or intake;

• participation in a pharmaceutical trial or exposure to investigational drugs within 1 month of the screening visit;

• currently seeking treatment for AUD

• have any other illness, condition, or use medication (psychotropic or antiretroviral), which in the opinion of the principal investigator (PI) and/or the admitting physician would preclude safe and/or successful completion of the study.

• Have cortisol levels > 5 mcg/dl but < 18 mcg/dL at baseline and an ACTH stimulation test that does not rule out adrenal insufficiency. Those with cortisol levels > 5 mcg/dl but < 18 mcg/dL at baseline and cortisol levels ≥ 18 after stimulation testing can be enrolled.

• Have been treated with any form of corticosteroid in the past 30 days.

• Have a history of endometrial hyperplasia, endometrial cancer, uterine polyps, or unexplained vaginal bleeding.

• Have uncontrolled hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg).

• Have potassium levels below the normal reference range. Low serum potassium must be corrected prior to dosing in patients with abnormal baseline potassium levels.

• Men taking testosterone replacement therapy.

• Men or women currently interested in fertility.

• Have underlying inflammatory or auto-immune disorders.

• Have elevated thyroid stimulating hormone (TSH) levels.

• Have diabetes.