This is a single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety and tolerability of the coadministration of up to 6 dose levels of ANS-6637 and EtOH in healthy male moderate alcohol drinkers. The study will include a screening visit, a qualification visit, a Treatment Phase and follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Ascending single doses administered orally.
Placebo administered orally.
Vince and Associates
Overland Park, Kansas, United States
Incidence and severity of adverse events
Time frame: Up to 36 hours postdose
Maximum observed serum concentration (Cmax)
Time frame: Up to 48 hours postdose
Time to maximum observed serum concentration (Tmax)
Time frame: Up to 48 hours postdose
Areas under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
Time frame: Up to 48 hours postdose
Ethanol Consumption
Time frame: Up to 6 hours postdose
Modified 5-Item Drug Effects Questionnaire (mDEQ-5)
Time frame: Up to 6 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.