HealthyPhase 1/2NCT07487909

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

A Phase 1/2 study testing Treatment A- Fexofenadine HCl 60mg, Treatment B- Naproxen sodium 220mg and Treatment C- SJP-001 280mg in people with Healthy, run by Sen-Jam Pharmaceutical at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Treatment A- Fexofenadine HCl 60mg, Treatment B- Naproxen sodium 220mg and Treatment C- SJP-001 280mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteCanada
Study dates: 30 Sep 2025to 21 Nov 2025
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Show all 27Show fewer

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.
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.
Heart rate > 100 beats per minute at screening.
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.
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).
Any clinically significant abnormal finding on physical examination or vital signs.
Subject has previously experienced an allergic reaction or adverse event associated with aspirin, NSAIDs, or antihistamine usage.
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.
Women who are breastfeeding.
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.
Concurrent participation in an investigational drug or device study, or use of any investigational drug within 30 days prior to screening.
Participant is unwilling to refrain from strenuous exercise (including weightlifting) 24 hours prior to admissions.
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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Conform Clinical
Toronto, Quebec

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions: Healthy
Being tested: Treatment A- Fexofenadine HCl 60mg, Treatment B- Naproxen sodium 220mg, Treatment C- SJP-001 280mg, Treatment D- Placebo-1, Treatment E- Fexofenadine HCl 120mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A- Fexofenadine HCl 60mgDrug
One oral capsule containing 60 mg fexofenadine HCl plus one matching placebo capsule
Treatment B- Naproxen sodium 220mgDrug
One oral capsule containing 220 mg naproxen sodium plus one matching placebo capsule
Treatment C- SJP-001 280mgDrug
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 D- Placebo-1Drug
Two oral placebo capsules matching the appearance of other study treatments
Treatment E- Fexofenadine HCl 120mgDrug
Two oral capsules containing 60 mg fexofenadine HCl (120 mg total) plus two matching placebo capsules
Treatment F- Naproxen sodium 440mgDrug
Two oral capsules containing 220 mg naproxen sodium (440mg maximum total) plus two matching placebo capsules
Treatment G- SJP-001 560mgDrug
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 H- Placebo 2Drug
Four oral placebo capsules matching the appearance of other study treatments

Study groups in NCT07487909
Study group	Role	What they receive
Treatment A- Fexofenadine HCl 60mg	Experimental	Low Dose - Fexofenadine 60mg single dose Receives: Drug: Treatment A- Fexofenadine HCl 60mg
Treatment B- Naproxen sodium 220mg	Experimental	Low Dose - Naproxen sodium 220mg single dose Receives: Drug: Treatment B- Naproxen sodium 220mg
Treatment C- SJP-001 280mg	Experimental	Low Dose - Fexofenadine 60mg + Naproxen sodium 220mg single dose Receives: Drug: Treatment C- SJP-001 280mg
Treatment D- Placebo-1	Placebo comparator	Low Dose - placebo Receives: Drug: Treatment D- Placebo-1
Treatment E- Fexofenadine HCl 120mg	Experimental	High Dose - Fexofenadine 60mg-2 tablets administered as single dose Receives: Drug: Treatment E- Fexofenadine HCl 120mg
Treatment F- Naproxen sodium 440mg	Experimental	High Dose - Naproxen sodium 220mg-2 tablets administered as single dose Receives: 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 Receives: Drug: Treatment G- SJP-001 560mg
Treatment H- Placebo 2	Placebo comparator	High Dose - placebo x 2 Receives: Drug: Treatment H- Placebo 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Cmax (Maximum plasma concentration)
Cmax
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1 to Day 23 post first dose administration

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Day 23 post first dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202521 Nov 2025

First posted23 Mar 2026
Study start30 Sep 2025
Primary completion21 Nov 2025
Study completion21 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07487909
Sponsor's protocol ID: SJP- 1- 01
Status last verified: Mar 2026
First submitted: 29 Sep 2025
Last updated: 23 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07487909
Acronym / sponsor ID: SJP- 1- 01
Conditions: Healthy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Sen-Jam PharmaceuticalUniversity, hospital or other
Collaborators: Cliantha Research
Study start: 30 Sep 2025 (actual)
Primary completion: 21 Nov 2025 (actual)
Study completion: 21 Nov 2025 (actual)
First posted: 23 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Treatment A- Fexofenadine HCl 60mg	Experimental	Drug: Treatment A- Fexofenadine HCl 60mgLow Dose - Fexofenadine 60mg single dose
Treatment B- Naproxen sodium 220mg	Experimental	Drug: Treatment B- Naproxen sodium 220mgLow Dose - Naproxen sodium 220mg single dose
Treatment C- SJP-001 280mg	Experimental	Drug: Treatment C- SJP-001 280mgLow Dose - Fexofenadine 60mg + Naproxen sodium 220mg single dose
Treatment D- Placebo-1	Placebo comparator	Drug: Treatment D- Placebo-1Low Dose - placebo
Treatment E- Fexofenadine HCl 120mg	Experimental	Drug: Treatment E- Fexofenadine HCl 120mgHigh Dose - Fexofenadine 60mg-2 tablets administered as single dose
Treatment F- Naproxen sodium 440mg	Experimental	Drug: Treatment F- Naproxen sodium 440mgHigh Dose - Naproxen sodium 220mg-2 tablets administered as single dose
Treatment G- SJP-001 560mg	Experimental	Drug: Treatment G- SJP-001 560mgHigh Dose - Naproxen sodium 220mg -2 tablets + Fexofenadine 60mg-2 tablets administered as a single dose
Treatment H- Placebo 2	Placebo comparator	Drug: Treatment H- Placebo 2High Dose - placebo x 2

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (27 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment A- Fexofenadine HCl 60mgOne oral capsule containing 60 mg fexofenadine HCl plus one matching placebo capsule	Drug	Treatment A- Fexofenadine HCl 60mg
Treatment B- Naproxen sodium 220mgOne oral capsule containing 220 mg naproxen sodium plus one matching placebo capsule	Drug	Treatment B- Naproxen sodium 220mg
Treatment C- SJP-001 280mgSJP-001 (One oral capsule containing 60 mg fexofenadine HCl plus one oral capsule containing no more than 275 mg (preferably 220 mg) naproxen sodium)	Drug	Treatment C- SJP-001 280mg
Treatment D- Placebo-1Two oral placebo capsules matching the appearance of other study treatments	Drug	Treatment D- Placebo-1
Treatment E- Fexofenadine HCl 120mgTwo oral capsules containing 60 mg fexofenadine HCl (120 mg total) plus two matching placebo capsules	Drug	Treatment E- Fexofenadine HCl 120mg
Treatment F- Naproxen sodium 440mgTwo oral capsules containing 220 mg naproxen sodium (440mg maximum total) plus two matching placebo capsules	Drug	Treatment F- Naproxen sodium 440mg
Treatment G- SJP-001 560mgJP-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])	Drug	Treatment G- SJP-001 560mg
Treatment H- Placebo 2Four oral placebo capsules matching the appearance of other study treatments	Drug	Treatment H- Placebo 2

Primary outcome

Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Cmax (Maximum plasma concentration)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)

5 secondary outcomes

PK characteristics of each drug by treatment group- Cmax (maximum plasma concentration)
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 23 post first dose administration
Overall hangover severity after administering SJP-001, after fexofenadine alone and after naproxen alone
Time frame: Day 1 to Day 23 post first dose administration
Quantitative differences in symptom profiles by treatment.
Time frame: Day 1 to Day 23 post first dose administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jackie Iversen study chair

Chief Clinical Officer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK) of two different doses of SJP001 administered in conjunction with alcohol to healthy adult subjects- Cmax (Maximum plasma concentration) (time frame: Day 1 to Day 23 post first dose administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07487909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.