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| Name | Class |
|---|---|
| Cliantha Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A- Fexofenadine HCl 60mg | Experimental | Low Dose - Fexofenadine 60mg single dose |
|
| Treatment B- Naproxen sodium 220mg | Experimental | Low Dose - Naproxen sodium 220mg single dose |
|
| Treatment C- SJP-001 280mg | Experimental | Low Dose - Fexofenadine 60mg + Naproxen sodium 220mg single dose |
|
| Treatment D- Placebo-1 | Placebo Comparator | Low Dose - placebo |
|
| Treatment E- Fexofenadine HCl 120mg | Experimental | High Dose - Fexofenadine 60mg-2 tablets administered as single dose |
|
| Treatment F- Naproxen sodium 440mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A- Fexofenadine HCl 60mg | Drug | One oral capsule containing 60 mg fexofenadine HCl plus one matching placebo capsule |
|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jackie Iversen | Chief Clinical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Conform Clinical | Toronto | Quebec | Canada |
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High Dose - Naproxen sodium 220mg-2 tablets administered as single dose
|
| Treatment G- SJP-001 560mg | Experimental | High Dose - Naproxen sodium 220mg -2 tablets + Fexofenadine 60mg-2 tablets administered as a single dose |
|
| Treatment H- Placebo 2 | Placebo Comparator | High Dose - placebo x 2 |
|
| Treatment B- Naproxen sodium 220mg | Drug | One oral capsule containing 220 mg naproxen sodium plus one matching placebo capsule |
|
| 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 D- Placebo-1 | Drug | Two oral placebo capsules matching the appearance of other study treatments |
|
| Treatment E- Fexofenadine HCl 120mg | Drug | Two oral capsules containing 60 mg fexofenadine HCl (120 mg total) plus two matching placebo capsules |
|
| Treatment F- Naproxen sodium 440mg | Drug | Two oral capsules containing 220 mg naproxen sodium (440mg maximum total) plus two matching placebo capsules |
|
| 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 H- Placebo 2 | Drug | Four oral placebo capsules matching the appearance of other study treatments |
|
| 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 |
| 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 |