A Study of SJP-001 in Comparison With Fexofenadine and Naproxen Administered With Alcohol (NCT07487909) | Clinical Trial Compass
CompletedPhase 1/2
A Study of SJP-001 in Comparison With Fexofenadine and Naproxen Administered With Alcohol
Canada47 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Acute illness within 14 days prior to screening visit.
✕. Allergic reaction within 7 days of screening visit.
✕
What they're measuring
1
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Cmax (Maximum plasma concentration)
Timeframe: Day 1 to Day 23 post first dose administration
2
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Tmax (Time to maximum plasma concentration)
Timeframe: Day 1 to Day 23 post first dose administration
3
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)
Timeframe: Day 1 to Day 23 post first dose administration
4
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- AUCinf (Total plasma exposure 1)
Timeframe: Day 1 to Day 23 post first dose administration
5
Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- t1/2 (Elimination half-life)
Timeframe: Day 1 to Day 23 post first dose administration
6
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)
. 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.
Timeframe: Day 1 to Day 23 post first dose administration
7
Pharmacodynamics (PD) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Single item hangover severity score
Timeframe: Day 1 to Day 23 post first dose administration
8
Pharmacodynamics (PD) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Multiple symptom hangover scores
Timeframe: Day 1 to Day 23 post first dose administration