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.
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).