Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol
Condition: Alcohol Dependence; Alcohol Interaction
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This study can be classified as a phase 1, single center, and drug study. This
      within-subjects experimental procedure will assess the effects of PT150 (900 mg qd) on the
      subjective effects of alcohol in non-treatment-seeking alcohol-experienced volunteers (to
      include military service members, veterans and/or civilians). Study duration will be six
      days; in-house; Day 0 (admission) until day six (final study day and day of discharge).
      Participants will undergo two alcohol challenges on day 1 separated by 4 hours (one with
      alcohol, 0.8g/kg; 16% ethanol by volume, and one with placebo beverage, 1% ethanol by volume,
      randomly ordered) and receive active study drug (PT150) from days 1-5 (after alcohol
      challenge for day 1). On day 5, the study drug dosing will be followed by two more alcohol
      challenges (alcohol and placebo beverage randomly ordered). Physiologic (e.g., vital signs,
      electrocardiogram), subjective and psychometric effects (e.g., mood, urge, craving, stimulant
      and sedative effects), and breath alcohol levels (BAL) will be obtained after the alcohol
      challenges. On day six, an electrocardiogram (ECG) will be performed, adverse events (AEs)
      and symptom checklist will be collected, including symptoms of adrenal insufficiency (AI),
      and a blood draw for electrolyte levels and cortisol will be collected in the morning
      followed by breakfast and discharge if laboratory tests are within normal ranges. All serious
      adverse events will be followed clinically until resolved or clinically stable.
      Pharmacodynamic and safety endpoints will be assessed during the alcohol challenge prior to,
      and after 5 days of PT150 treatment, when PT150 has reached steady state. For females, a
      follow-up visit will be scheduled to occur at least 14 days after the final dose of PT150 is
      administered to ensure pregnancy does not occur. The objectives of the study are to compare
      pharmacodynamics and safety endpoints following an alcohol challenge prior to and concurrent
      with PT150. Given available pre-clinical and clinical evidence for the salutatory effect of
      glucocorticoid receptor (GR) antagonists on alcohol withdrawal, it was hypothesized that
      PT150 will not significantly alter pharmacodynamic measures and will be safe and
      well-tolerated under conditions of alcohol consumption.
    

Intervention name(s): PT150; Beverage
Intervention type(s): Drug; Other
Intervention description(s): Intervention 1 includes PT150 with alcohol consumption; Alcohol beverage will be prepared by an in-house pharmacist at the MEDVAMC in a volume of 450 ml for a 70 kg individual and adjusted for body weight by varying the volume. Alcohol will be administered in a concentration of 16% alcohol (Everclear, St. Louis, MO) by volume in grape Kool-Aid (Kraft Foods, Northfield, IL). Placebo will be prepared in the same manner but contain 1% alcohol to mask taste.
Other intervention name(s): Formerly ORG34517; Placebo drink and ethanol drink
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Apart from the Research Pharmacists, all others engaged with this study (participants and study team) will be masked to alcohol challenge order.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Alcohol; Alcoholic; Alcoholism; Alcohol abuse; Alcohol interaction; Alcohol Use Disorder; Alcohol use; Alcohol dependence; Alcohol dependent; Ethanol abuse; Ethanol use