Healthy
Conditions
Brief summary
This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (SJP-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 amount of alcohol may vary from subject to subject, however each subject will consume the same types and amounts of alcohol on each subsequent treatment day as consumed on the first.
Detailed description
At each of four treatment visits, each separated by a minimum 7-day washout (i.e., the treatment day followed by a minimum of 6 subsequent non-treatment days), subjects will be administered SJP-001, placebo, fexofenadine alone and naproxen alone. Subjects will be randomized equally to one of four treatment sequences, according to a schedule prepared prior to the start of the study. Treatments will be administered 15 minutes before the start of a maximum 3-hour interval during which subjects will drink their choice of a selection of alcoholic and non-alcohol beverages. The amount of alcohol consumed will be targeted to achieve a breath alcohol content (BrAC) of 0.08%, a level estimated to be sufficient to produce a hangover the following day.
Interventions
DRUGTreatment A- Fexofenadine HCl 60mg
One oral capsule containing 60 mg fexofenadine HCl plus one matching placebo capsule
DRUGTreatment B- Naproxen sodium 220mg
One oral capsule containing 220 mg naproxen sodium plus one matching placebo capsule
DRUGTreatment C- SJP-001 280mg
SJP-001 (One oral capsule containing 60 mg fexofenadine HCl plus one oral capsule containing no more than 275 mg (preferably 220 mg) naproxen sodium)
DRUGTreatment D- Placebo-1
Two oral placebo capsules matching the appearance of other study treatments
DRUGTreatment E- Fexofenadine HCl 120mg
Two oral capsules containing 60 mg fexofenadine HCl (120 mg total) plus two matching placebo capsules
DRUGTreatment F- Naproxen sodium 440mg
Two oral capsules containing 220 mg naproxen sodium (440mg maximum total) plus two matching placebo capsules
DRUGTreatment G- SJP-001 560mg
JP-001 (Two oral capsules containing 60 mg fexofenadine HCl \[120 mg total\] plus two oral capsules containing 220 mg naproxen sodium (560 mg) maximum total\])
DRUGTreatment H- Placebo 2
Four oral placebo capsules matching the appearance of other study treatments
Sponsors
Sen-Jam Pharmaceutical
Cliantha Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy men or women between 18 and 65 years inclusive. 2. Good general health as determined by a thorough medical history and physical examination including vital signs. Repeat testing at Screening is acceptable for out- of range vital signs. 3. Subject is a self-reported moderate drinker of alcohol, sometimes or regularly 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 54-72 kg female drinking 2 to 5 drinks in 2 to 3 hours, respectively, and a 72-95 kg 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 18 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 serum pregnancy test at screening and a negative urine pregnancy test upon admission for each treatment visit and be using an acceptable method of contraception. 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.
Exclusion criteria
1. Acute illness within 14 days prior to screening visit. 2. Allergic reaction within 7 days of screening visit. 3. Vaccination administration within 7 days of screening visit. 4. Clinically significant, unstable medical illness. 5. AST, ALT or Bilirubin value greater than \>1.5x ULN. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designees. 6. Estimated glomerular filtration rate (eGFR) \< 80 mL/min (determined with an appropriate method by the reporting laboratory). Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designees. 7. Prothrombin time \> 1.3(s). Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designees. 8. Any abnormal laboratory value considered by the investigator to be clinically significant. 9. Evidence or history of clinically significant autoimmune, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease that would make implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator. 10. History of cancer or diabetes, (excluding subjects with resected basal cell carcinoma and squamous cell carcinoma at the discretion of the PI). 11. Subject has a previous or current Substance-Related Disorder as defined by DSM-5. 12. A score of 8 or greater on the AUDIT scale. 13. 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). 14. Positive alcohol Breathalyzer test at screening or check-in for any treatment visit. 15. Positive urine drug screen at screening or at check-in for any treatment visit. 16. Systolic blood pressure (BP) outside the range of 100 and 140 mmHg, diastolic BP outside the range of 50 and 90 mmHg, at Screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once. 17. Heart rate \> 100 beats per minute at screening. 18. 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. 19. Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition, including anxiety and/or depression within the past 6 months). 20. Any clinically significant abnormal finding on physical examination or vital signs. 21. Subject has previously experienced an allergic reaction or adverse event associated with aspirin, NSAIDs, or antihistamine usage. 22. Subject requires the use of any prescription medication 14 days prior to day 1, over the counter (OTC) oral pain medication(s) 7 days prior to first dose (paracetamol, oral contraceptives and vitamins are permissible), or any prescription medication or over the counter medication on the day of dosing during the study (oral contraceptives are permissible). This includes use during previous treatment periods during the study. 23. Women who are breastfeeding. 24. 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. 25. Concurrent participation in an investigational drug or device study, or use of any investigational drug within 30 days prior to screening. 26. Participant is unwilling to refrain from strenuous exercise (including weightlifting) 24 hours prior to admissions. 27. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Cmax (Maximum plasma concentration) | Day 1 to Day 23 post first dose administration | Cmax |
| Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Tmax (Time to maximum plasma concentration) | Day 1 to Day 23 post first dose administration | Tmax |
| Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- AUC0-24 (Total plasma exposure from dosing through 24 hours after dosing) | Day 1 to Day 23 post first dose administration | AUC0-24 |
| Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- AUCinf (Total plasma exposure 1) | Day 1 to Day 23 post first dose administration | AUCinf |
| Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- t1/2 (Elimination half-life) | Day 1 to Day 23 post first dose administration | t1/2 |
| Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- AUC% extrap (Percentage of AUC derived by extrapolation from the last observed plasma concentration) | Day 1 to Day 23 post first dose administration | — |
| Pharmacodynamics (PD) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Single item hangover severity score | Day 1 to Day 23 post first dose administration | Single item hangover severity score is a single-value subjective self-report of hangover severity on a 0 to 10 scale (0=none;10=worst) |
| Pharmacodynamics (PD) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Multiple symptom hangover scores | Day 1 to Day 23 post first dose administration | Multiple symptom hangover scores is a multi-value, multi-symptom scores derived from individual subjective self-reporting of a spectrum of hangover symptoms in terms of incidence and severity. (23 symptoms scored 0-10; 0=none, 10=worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK characteristics of each drug by treatment group- Cmax (maximum plasma concentration) | Day 1 to Day 23 post first dose administration | Drug to drug analysis Fexofenadine administered as SJP-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as SJP-001with administration of naproxen alone. |
| PK characteristics of each drug by treatment group- AUC0-t (area under curve from 0 time to t. | Day 1 to Day 23 post first dose administration | Drug to drug analysis Fexofenadine administered as SJP-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as SJP-001with administration of naproxen alone. |
| PK characteristics of each drug by treatment group- AUC0-inf (area under curve from 0 to infinity. | Day 1 to Day 23 post first dose administration | Drug to drug analysis Fexofenadine administered as SJP-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as SJP-001with administration of naproxen alone. |
| Overall hangover severity after administering SJP-001, after fexofenadine alone and after naproxen alone | Day 1 to Day 23 post first dose administration | Single item scale and scores on a multi-symptom scale) will be analyzed and compared between treatments, including placebo, by 2-way (Treatment x Time) ANOVA, for each dose level. |
| Quantitative differences in symptom profiles by treatment. | Day 1 to Day 23 post first dose administration | Number of participants experiencing treatment-emergent adverse events (TEAEs) in each treatment arm. Severity was assessed by the investigator as mild (awareness of sign/symptom but easily tolerated), moderate (enough discomfort to interfere with usual activity, may warrant intervention), or severe (incapacitating, inability to perform usual activities, significantly affects clinical status, warrants intervention). Causality was assessed as definitely related, possibly related, or unrelated to study drug. |
Countries
Canada
Contacts
STUDY_CHAIRJackie Iversen
Chief Clinical Officer
Outcome results
None listed