A Study of SJP-001 in Comparison With Fexofenadine and Naproxen Administered With Alcohol

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Treatment A- Fexofenadine HCl 60mg; Drug: Treatment B- Naproxen sodium 220mg; Drug: Treatment C- SJP-001 280mg; Drug: Treatment D- Placebo-1; Drug: Treatment E- Fexofenadine HCl 120mg; Drug: Treatment F- Naproxen sodium 440mg; Drug: Treatment G- SJP-001 560mg; Drug: Treatment H- Placebo 2

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Toronto, Quebec, Canada
      • Conform Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A- Fexofenadine HCl 60mg; Low Dose - Fexofenadine 60mg single dose	Drug: Treatment A- Fexofenadine HCl 60mg; One oral capsule containing 60 mg fexofenadine HCl plus one matching placebo capsule
Experimental: Treatment B- Naproxen sodium 220mg; Low Dose - Naproxen sodium 220mg single dose	Drug: Treatment B- Naproxen sodium 220mg; One oral capsule containing 220 mg naproxen sodium plus one matching placebo capsule
Experimental: Treatment C- SJP-001 280mg; Low Dose - Fexofenadine 60mg + Naproxen sodium 220mg single dose	Drug: Treatment 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)
Placebo Comparator: Treatment D- Placebo-1; Low Dose - placebo	Drug: Treatment D- Placebo-1; Two oral placebo capsules matching the appearance of other study treatments
Experimental: Treatment E- Fexofenadine HCl 120mg; High Dose - Fexofenadine 60mg-2 tablets administered as single dose	Drug: Treatment E- Fexofenadine HCl 120mg; Two oral capsules containing 60 mg fexofenadine HCl (120 mg total) plus two matching placebo capsules
Experimental: Treatment F- Naproxen sodium 440mg; High Dose - Naproxen sodium 220mg-2 tablets administered as single dose	Drug: Treatment F- Naproxen sodium 440mg; Two oral capsules containing 220 mg naproxen sodium (440mg maximum total) plus two matching placebo capsules
Experimental: Treatment G- SJP-001 560mg; High Dose - Naproxen sodium 220mg -2 tablets + Fexofenadine 60mg-2 tablets administered as a single dose	Drug: Treatment 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])
Placebo Comparator: Treatment H- Placebo 2; High Dose - placebo x 2	Drug: Treatment H- Placebo 2; Four oral placebo capsules matching the appearance of other study treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Cmax (Maximum plasma concentration)	Cmax	Day 1 to Day 23 post first dose administration
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Tmax (Time to maximum plasma concentration)	Tmax	Day 1 to Day 23 post first dose administration
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)	AUC0-24	Day 1 to Day 23 post first dose administration
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- AUCinf (Total plasma exposure 1)	AUCinf	Day 1 to Day 23 post first dose administration
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- t1/2 (Elimination half-life)	t1/2	Day 1 to Day 23 post first dose administration
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	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)	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- Multiple symptom hangover scores	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)	Day 1 to Day 23 post first dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK characteristics of each drug by treatment group- Cmax (maximum plasma concentration)	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.	Day 1 to Day 23 post first dose administration
PK characteristics of each drug by treatment group- AUC0-t (area under curve from 0 time to t.	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.	Day 1 to Day 23 post first dose administration
PK characteristics of each drug by treatment group- AUC0-inf (area under curve from 0 to infinity.	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.	Day 1 to Day 23 post first dose administration
Overall hangover severity after administering SJP-001, after fexofenadine alone and after naproxen alone	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.	Day 1 to Day 23 post first dose administration
Quantitative differences in symptom profiles by treatment.	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.	Day 1 to Day 23 post first dose administration

Collaborators and Investigators

• Sponsor: Sen-Jam Pharmaceutical
• Collaborators: Cliantha Research
• Investigators: Study Chair: Jackie Iversen, Chief Clinical Officer

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Actual): November 21, 2025
• Study Completion (Actual): November 21, 2025

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SJP- 1- 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No