Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)
Condition: Potential Treatment for Alcohol Dependence-Alcohol Interaction
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

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).
    

Detailed description: 
      This study can be classified as a phase 1, single center, and drug-drug interaction (DDI)
      study. The within-subjects' experimental procedures will 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). The specific aim
      of this study is to evaluate the safety and tolerability of PT150 (a novel, selective
      Glucocorticoid receptor (GR) antagonist) in combination with alcohol and to determine the
      amount of PT150 and alcohol in blood (i.e., the pharmacokinetic (PK) interactions between
      alcohol and PT150) in 10 non-treatment seeking participants. The purpose of this study is to
      assess the possibility of any adverse interactions between alcohol and PT150. While PT150
      might be effective in the treatment of AUD, because alcohol can affect the way that PT150 is
      metabolized in the body, we first need to determine 1) that it is safe to take PT150 in
      combination with alcohol, and 2) the amount of PT150 and alcohol in blood after PT150 has
      reached steady state. This study population will be drawn from adults of any race or
      ethnicity, males, and females who are post-menopausal, undergoing hormone replacement
      treatment at a stable dosage for at least 3 months, infertile and not hormone cycling, or
      using approved non-hormonal contraception for at least two weeks after the last dose.
      Potential enrollees will be drawn of those NOT seeking treatment for alcohol use disorder
      (AUD). Statistical goals for the study are to evaluate the pharmacokinetics of PT150 given in
      combination with exposure to alcohol. The primary objective includes assessing if measures of
      concentration and timing of PT150 levels in the blood differ between the PT150 challenge
      (challenge on Day 8 and continually observed through Day 9) in combination with alcohol
      (ethanol beverage) compared to the steady-state PT150 challenge, absent alcohol challenge, on
      Day 7. Secondary objectives are to determine if measures of concentration and timing of BAL
      in the blood differ between the active alcohol challenges only (Day 1/baseline) and PT150
      challenges in combination with alcohol challenges (Day 8). Other secondary outcomes include
      evaluating health and safety outcomes as well as withdrawal from alcohol. After completion of
      the screening period, the remaining study duration will proceed as follows for each
      participant: Admission for an initial 1-day in-patient stay; Discharge followed by 4 days of
      outpatient visits; Readmission for a 4-day inpatient stay; and 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 has not occurred. This results in a total participant duration of 10 days.
    

Intervention name(s): PT150; Beverage
Intervention type(s): Drug; Other
Intervention description(s): Intervention 1 includes PT150 with alcohol consumption; The 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 juice or another flavored beverage. Participants will be allowed 30 minutes to consume the beverages.
Other intervention name(s): Formerly ORG34517; Ethanol beverage
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol; Alcoholic; Alcoholism; Alcohol abuse; Alcohol interaction; Alcohol Use Disorder; Alcohol use; Alcohol dependence; Alcohol dependent; Post Traumatic Stress Disorder; Substance use Disorder; Ethanol abuse; Ethanol use; Pharmacokinetics