AS140026-A3c Verrico PK

Protocol Title: Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517)

Objective: to determine pharmacokinetic (PK) interactions between the glucocorticoid receptor antagonist, PT150, and ethanol in healthy volunteers.

Hypothesis: to evaluate PK measures of 1) alcohol, 2) PT150 at steady-state, and 3) alcohol with PT150 at steady-state.

Key Exclusion/Inclusion Criteria: Demonstrate willingness and ability to provide informed consent for study participation. Be 21-64 years old. Not demonstrate a need for medical detoxification to mitigate alcohol withdrawal symptoms. Not be seeking treatment for alcohol use. Not be using prescription or non-prescription drugs. Not have primary adrenal insufficiency, hypopituitarism, or hypothyroidism. Have acceptable blood laboratory test results

Subject Target Completion: n = 10

Study Synopsis: This is a phase I, open-label, single-center, crossover study to evaluate PK interactions between the glucocorticoid receptor antagonist, PT150 (900 mg, daily), and ethanol in alcohol-experienced, non-treatment-seeking adults. The purpose of this research study is to assess the safety and tolerability of PT150 in combination with alcohol and to determine the amount of PT150 and alcohol in blood when co-administered.