Last updated on June 2018

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

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03548714

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