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

NCT07487909 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: SJP- 1- 01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• PK characteristics of each drug by treatment group- Cmax (maximum plasma concentration)

  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.

  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.

  Day 1 to Day 23 post first dose administration

• Overall hangover severity after administering SJP-001, after fexofenadine alone and after naproxen alone

  Day 1 to Day 23 post first dose administration

• Quantitative differences in symptom profiles by treatment.

  Day 1 to Day 23 post first dose administration

Study Arms (8)

Treatment A- Fexofenadine HCl 60mg

EXPERIMENTAL

Low Dose - Fexofenadine 60mg single dose

Drug: Treatment A- Fexofenadine HCl 60mg

Treatment B- Naproxen sodium 220mg

EXPERIMENTAL

Low Dose - Naproxen sodium 220mg single dose

Drug: Treatment B- Naproxen sodium 220mg

Treatment C- SJP-001 280mg

EXPERIMENTAL

Low Dose - Fexofenadine 60mg + Naproxen sodium 220mg single dose

Drug: Treatment C- SJP-001 280mg

Treatment D- Placebo-1

PLACEBO COMPARATOR

Low Dose - placebo

Drug: Treatment D- Placebo-1

Treatment E- Fexofenadine HCl 120mg

EXPERIMENTAL

High Dose - Fexofenadine 60mg-2 tablets administered as single dose

Drug: Treatment E- Fexofenadine HCl 120mg

Treatment F- Naproxen sodium 440mg

EXPERIMENTAL

High Dose - Naproxen sodium 220mg-2 tablets administered as single dose

Drug: Treatment F- Naproxen sodium 440mg

Treatment G- SJP-001 560mg

EXPERIMENTAL

High Dose - Naproxen sodium 220mg -2 tablets + Fexofenadine 60mg-2 tablets administered as a single dose

Drug: Treatment G- SJP-001 560mg

Treatment H- Placebo 2

PLACEBO COMPARATOR

High Dose - placebo x 2

Drug: Treatment H- Placebo 2

Interventions

Treatment C- SJP-001 280mg DRUG

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)

Treatment C- SJP-001 280mg

Treatment D- Placebo-1 DRUG

Two oral placebo capsules matching the appearance of other study treatments

Treatment D- Placebo-1

Treatment G- SJP-001 560mg DRUG

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\])

Treatment G- SJP-001 560mg

Treatment H- Placebo 2 DRUG

Four oral placebo capsules matching the appearance of other study treatments

Treatment H- Placebo 2

Treatment E- Fexofenadine HCl 120mg DRUG

Two oral capsules containing 60 mg fexofenadine HCl (120 mg total) plus two matching placebo capsules

Treatment E- Fexofenadine HCl 120mg

Treatment F- Naproxen sodium 440mg DRUG

Two oral capsules containing 220 mg naproxen sodium (440mg maximum total) plus two matching placebo capsules

Treatment F- Naproxen sodium 440mg

Treatment A- Fexofenadine HCl 60mg DRUG

One oral capsule containing 60 mg fexofenadine HCl plus one matching placebo capsule

Treatment A- Fexofenadine HCl 60mg

Treatment B- Naproxen sodium 220mg DRUG

One oral capsule containing 220 mg naproxen sodium plus one matching placebo capsule

Treatment B- Naproxen sodium 220mg

Eligibility Criteria

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

You may qualify if:

• Healthy men or women between 18 and 65 years inclusive.
• 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.
• 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.
• Subject has prequalified as likely hangover-sensitive based on pre-study questionnaire.
• Body mass index between 18 and 32 kg/m2, inclusive.
• Report a regular, habitual bedtime between 21:30 and 24:00.
• 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.
• 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.

You may not qualify if:

• Acute illness within 14 days prior to screening visit.
• Allergic reaction within 7 days of screening visit.
• Vaccination administration within 7 days of screening visit.
• Clinically significant, unstable medical illness.
• 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.
• 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.
• Prothrombin time \> 1.3(s). Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designees.
• Any abnormal laboratory value considered by the investigator to be clinically significant.
• 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.
• History of cancer or diabetes, (excluding subjects with resected basal cell carcinoma and squamous cell carcinoma at the discretion of the PI).
• 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 screening or check-in for any treatment visit.
• Positive urine drug screen at screening or at check-in for any treatment visit.

Sponsors & Collaborators

• Sen-Jam Pharmaceutical: lead
• Cliantha Research: collaborator

Study Sites (1)

Conform Clinical

Toronto, Quebec, Canada

Location

Study Officials

• Jackie Iversen

  Chief Clinical Officer

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: March 23, 2026
• Study Start: September 30, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)