Safety and Efficacy of a Combination Product for the Prevention of Veisalgia

A Double-blind Placebo-controlled 4-Way Crossover Study to Evaluate the Efficacy of JMI-001 (an Over-the-counter Pain Medicine and an Antihistamine) in the Prophylaxis of Veisalgia in Healthy Volunteers

The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.

Some people who consume alcohol in moderation experience veisalgia. These symptoms include a long list of adverse effects that include headache, fatigue and thirst. The mechanism by which these effects occur has not been fully elucidated. Although, it has been documented that alcohol causes the release of a large number of substances into the blood stream that cause a number of physiologic changes.

A 4-arm study will help to determine the effect each agent contributes to decreasing the alcohol induces physiologic changes and the effect when the two agents are delivered concurrently.

Inclusion Criteria:

• Healthy, nonsmoking men or women between 25 and 65 years inclusive
• Good general health as determined by a thorough medical history and physical examination including vital signs
• Subject is a self-reported moderate drinker of alcohol. Moderate drinking can be approximated with a blood alcohol concentration (BAC) of 0.04 - 0.11%. The 0.04% - 0.11% BAC correlates approximately with a 120-160 pound female drinking 2 to 5 drinks in 2 to 3 hours, respectively, and a 160-200 pound male drinking 3 to 7 drinks in 2 to 3 hours, respectively.
• Subject has had a moderate to heavy drinking episode in the past 90 days that produced hangover symptoms
• Subject is knowledgeable of the amount of alcohol he/she needs to consume over a 2 to 3 hour period of time to produce hangover symptoms
• Body mass index between 19 and 32 kg/m2, inclusive
• Report a regular, habitual bedtime between 21:30 and 24:00
• Females of childbearing potential must be using an acceptable method of contraception (see Section 8.5) or have been surgically sterilized and have a negative urine pregnancy test at screening and upon admission for each treatment visit
• Subject is capable of understanding the requirements of the study and to give written informed consent
• Subject is able to follow study instructions and is willing to complete all study visits and procedures

Exclusion Criteria:

• Acute illness within 14 days prior to screening visit

• Allergic reaction or upper respiratory tract infection within 7 days of screening visit

• Vaccination administration within 7 days of screening visit

• Clinically significant, unstable medical illness

• Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease

• History of cancer or diabetes

• Subject has a previous or current Substance-Related Disorder as defined by DSM-5

• Self-report of a usual consumption of more than 14 units of alcohol per week. One unit of alcohol is equivalent to 12 ounces of beer, 4 ounces of wine, or

  1 ounce of liquor

• Self-report of recent (within one month) or current use of smoked or chewed tobacco products, or use of nicotine (e.g., nicotine gum or patch)

• Positive alcohol breathalyzer test at screening or at check-in for any treatment visit

• Positive urine drug screen at screening or at check-in for any treatment visit

• A supine blood pressure > 140/90 mm/Hg at screening

• Heart rate > 100 beats per minute at screening

• Subjects who are unwilling to forgo caffeine consumption with or following dinner on each treatment night or who are unwilling to comply with study restrictions for prohibited medications/ foods throughout study participation.

• Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition

• Any clinically significant abnormal finding on physical examination or vital signs

• Positive pregnancy test at screening or at check-in for any treatment visit

• Subject has previously experienced an allergic reaction or adverse event associated with aspirin, NSAIDs, or antihistamine usage, including a reaction of not effective

• Subject is taking any prescription or over-the-counter oral pain medication(s) for any reason

• Subject is taking prescription or over-the-counter antihistamine(s)

• Women who are pregnant or breastfeeding

• Any medical condition or any condition or situation that in the investigator's opinion may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study

• Concurrent participation in an investigational drug or device study, or use of any investigational drug within 30 days prior to screening