A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of JMI-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol.

Sen-Jam Pharmaceutical0 sites48 target enrollmentAugust 2017

Overview

Brief Summary

This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on different study days, in conjunction with a quantity of alcohol estimated to be sufficient to produce a hangover the next day. The primary objective of the study is the evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects.

Detailed Description

This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on different study days, in conjunction with a quantity of alcohol estimated to be sufficient to produce a hangover the next day. The primary objective of the study is the evaluate the pharmacokinetics and pharmacodynamics of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects. The secondary objective of this study is to compare the PK characteristics of fexofenadine administered as JMI-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as JMI-001 with administration of naproxen alone. To compare overall hangover severity after administering JMI-001 with overall hangover severity after administration of fexofenadine alone or naproxen alone. To analyze possible quantitative differences in symptom profiles by treatment.

Registry

clinicaltrials.gov

Start Date

August 2017

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Sen-Jam Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, non-smoking men or women between 21 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, typically consuming 2 to 7 units of alcohol. Moderate drinking can be approximated with a 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 prequalified as likely hangover-sensitive based on pre-study questionnaire;
•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 have a negative urine pregnancy test at screening and upon admission for each treatment visit and be using an acceptable method of contraception (see Section 8.5);
•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 autoimmune, 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;
•A score of 8 or greater on the AUDIT scale;
•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 check-in for any treatment visit;

Arms & Interventions

JMI-001

JMI-001 is a combination product of naproxen 220mg and fexofenadine 60mg (Dose Level one) then a combination product of naproxen 440mg and fexofenadine 120mg (Dose Level Two).

Intervention: JMI-001