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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

Trial details

NCT IDNCT07487909

SponsorSen-Jam Pharmaceutical

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-21

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

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

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria