Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001

NCT03183297 | Unknown Phase 1 FDA Drug

• 1 other identifier: SJP-1-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Veisalgia

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration (Cmax)

  Maximum Plasma Concentration of each drug measured in ng/mL

  24 hours

• Time to Maximum Plasma Concentration (Tmax)

  Time to achieve the (Cmax) for each drug measured in hours

  24 hours

• Area Under the Curve (AUC)

  Area Under the Curve for each drug measured in h\*ng/mL

  24 hours

• Elimination half-life

  Elimination half-life measured in hours

  24 hours

Secondary Outcomes (2)

• Hangover Severity Score

  24 hours

• Multiple Symptom Hangover Severity Score

  24 hours

Study Arms (4)

JMI-001

EXPERIMENTAL

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).

Drug: JMI-001

Naproxen

ACTIVE COMPARATOR

Naproxen 220mg or 440mg

Drug: Naproxen; Drug: placebo

Fexofenadine

ACTIVE COMPARATOR

fexofenadine 60mg or 120mg

Drug: Fexofenadine; Drug: placebo

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

JMI-001 DRUG

JMI-001, a combination product of naproxen and fexofenadine

JMI-001

Naproxen DRUG

Naproxen sodium 220mg

Naproxen

Fexofenadine DRUG

Fexofenadine 60mg

Fexofenadine

placebo DRUG

placebo comparator

Fexofenadine; Naproxen; Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Healthy, non-smoking men or women between 21 and 65 years inclusive; 2. Good general health as determined by a thorough medical history and physical examination including vital signs; 3. 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; 4. Subject has prequalified as likely hangover-sensitive based on pre-study questionnaire; 5. Body mass index between 19 and 32 kg/m2, inclusive ; 6. Report a regular, habitual bedtime between 21:30 and 24:00; 7. 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); 8. Subject is capable of understanding the requirements of the study and to give written informed consent; 9. Subject is able to follow study instructions and is willing to complete all study visits and procedures.

You may not qualify if:

• \. Acute illness within 14 days prior to screening visit; 2. Allergic reaction or upper respiratory tract infection within 7 days of screening visit; 3. Vaccination administration within 7 days of screening visit; 4. Clinically significant, unstable medical illness; 5. Evidence or history of clinically significant autoimmune, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease; 6. History of cancer or diabetes; 7. Subject has a previous or current Substance-Related Disorder as defined by DSM 5; 8. A score of 8 or greater on the AUDIT scale; 9. 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); 10. Positive alcohol Breathalyzer test at check-in for any treatment visit; 11. Positive urine drug screen at screening or at check-in for any treatment visit; 12. A seated blood pressure \> 140/90 mm/Hg at screening; 13. Heart rate \> 100 beats per minute at screening; 14. 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; 15. Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition; 16. Any clinically significant abnormal finding on physical examination or vital signs; 17. Subject has previously experienced an allergic reaction or adverse event associated with aspirin, NSAIDs, or antihistamine usage; 18. Subject requires the use of any prescription or over-the-counter (OTC) oral pain medication(s) on study treatment days; 19. Women who are breastfeeding; 20. 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; 21. Concurrent participation in an investigational drug or device study, or use of any investigational drug within 30 days prior to screening.

Sponsors & Collaborators

• Sen-Jam Pharmaceutical: lead

MeSH Terms

Interventions

Naproxen; fexofenadine

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Magdy L Shenouda, MD

  Clinilabs, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Cassidy

CONTACT

646-215-6400; mcassidy@clinilabs.com

Toshiko Kammerra

CONTACT

646-215-6400; tkammerra@clinilabs.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Double-Blind, Placebo-Controlled, 4-Way Crossover Study

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: August 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share