VeisalgiaPhase 1NCT03183297
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001
A Phase 1 study testing JMI-001, Naproxen and Fexofenadine in people with Veisalgia, run by Sen-Jam Pharmaceutical.
Trial summary
This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Veisalgia
- What is being tested?
- JMI-001, Naproxen and Fexofenadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Dec 2017
- Phase
- Phase 1
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Healthy, non-smoking men or women between 21 and 65 years inclusive; 2. Good general health as determined by a thorough medical history and physical examination including vital signs; 3. Subject is a self-reported moderate drinker of alcohol, typically 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 120-160 pound female drinking 2 to 5 drinks in 2 to 3 hours, respectively, and a 160-200 pound male drinking 3 to 7 drinks in 2 to 3 hours, respectively; 4. Subject has prequalified as likely hangover-sensitive based on pre-study questionnaire; 5. Body mass index between 19 and 32 kg/m2, inclusive ; 6. Report a regular, habitual bedtime between 21:30 and 24:00; 7. Females of childbearing potential must have a negative urine pregnancy test at screening and upon admission for each treatment visit and be using an acceptable method of contraception (see Section 8.5); 8. Subject is capable of understanding the requirements of the study and to give written informed consent; 9. Subject is able to follow study instructions and is willing to complete all study visits and procedures.
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Who cannot join
- 1. Acute illness within 14 days prior to screening visit; 2. Allergic reaction or upper respiratory tract infection within 7 days of screening visit; 3. Vaccination administration within 7 days of screening visit; 4. Clinically significant, unstable medical illness; 5. Evidence or history of clinically significant autoimmune, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease; 6. History of cancer or diabetes; 7. Subject has a previous or current Substance-Related Disorder as defined by DSM 5; 8. A score of 8 or greater on the AUDIT scale; 9. 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); 10. Positive alcohol Breathalyzer test at check-in for any treatment visit; 11. Positive urine drug screen at screening or at check-in for any treatment visit; 12. A seated blood pressure > 140/90 mm/Hg at screening; 13. Heart rate > 100 beats per minute at screening; 14. 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; 15. Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition; 16. Any clinically significant abnormal finding on physical examination or vital signs; 17. Subject has previously experienced an allergic reaction or adverse event associated with aspirin, NSAIDs, or antihistamine usage; 18. Subject requires the use of any prescription or over-the-counter (OTC) oral pain medication(s) on study treatment days; 19. Women who are breastfeeding; 20. 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; 21. Concurrent participation in an investigational drug or device study, or use of any investigational drug within 30 days prior to screening.
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Trial locations and contacts
No sites are listed yet.
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 JMI-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 (JMI-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 primary objective of the study is the evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects.
Read the detailed description
This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-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 primary objective of the study is the evaluate the pharmacokinetics and pharmacodynamics of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects. The secondary objective of this study is to compare the PK characteristics of fexofenadine administered as JMI-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as JMI-001 with administration of naproxen alone. To compare overall hangover severity after administering JMI-001 with overall hangover severity after administration of fexofenadine alone or naproxen alone. To analyze possible quantitative differences in symptom profiles by treatment.
- Conditions
- Veisalgia
- Being tested
- JMI-001, Naproxen, Fexofenadine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMI-001Drug
JMI-001, a combination product of naproxen and fexofenadine
NaproxenDrug
Naproxen sodium 220mg
FexofenadineDrug
Fexofenadine 60mg
placeboDrug
placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| JMI-001 | Experimental | JMI-001 is a combination product of naproxen 220mg and fexofenadine 60mg (Dose Level one) then a combination product of naproxen 440mg and fexofenadine 120mg (Dose Level Two). Receives: Drug: JMI-001 |
| Naproxen | Active comparator | Naproxen 220mg or 440mg Receives: Drug: Naproxen; Drug: placebo |
| Fexofenadine | Active comparator | fexofenadine 60mg or 120mg Receives: Drug: Fexofenadine; Drug: placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration of each drug measured in ng/mL
Measured: 24 hours
Time to Maximum Plasma Concentration (Tmax)
Time to achieve the (Cmax) for each drug measured in hours
Measured: 24 hours
Area Under the Curve (AUC)
Area Under the Curve for each drug measured in h*ng/mL
Measured: 24 hours
Elimination half-life
Elimination half-life measured in hours
Measured: 24 hours
Secondary outcomes (2)
Hangover Severity Score
Single item Hangover Score subjectively measured by the subject from 0=no symptoms to 10=worst symptoms
Measured: 24 hours
Multiple Symptom Hangover Severity Score
A composite score derived from a spectrum of hangover symptoms (23-items) with each symptom subjectively measured by the subject from 0=no symptom to 10=worst symptom
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startAug 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VeisalgiaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Double-Blind, Placebo-Controlled, 4-Way Crossover Study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sen-Jam Pharmaceutical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdy L Shenouda, MD, Principal investigator, Clinilabs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183297
- Sponsor's protocol ID
- SJP-1-01
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. 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 JMI-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol.
- ClinicalTrials.gov ID
- NCT03183297
- Acronym / sponsor ID
- SJP-1-01
- Conditions
- Veisalgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sen-Jam PharmaceuticalUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jun 2017 (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.
This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-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 primary objective of the study is the evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects.
Detailed description
This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-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 primary objective of the study is the evaluate the pharmacokinetics and pharmacodynamics of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects. The secondary objective of this study is to compare the PK characteristics of fexofenadine administered as JMI-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as JMI-001 with administration of naproxen alone. To compare overall hangover severity after administering JMI-001 with overall hangover severity after administration of fexofenadine alone or naproxen alone. To analyze possible quantitative differences in symptom profiles by treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- A Double-Blind, Placebo-Controlled, 4-Way Crossover Study
| Arm | Type | Receives |
|---|---|---|
| JMI-001 | Experimental | Drug: JMI-001JMI-001 is a combination product of naproxen 220mg and fexofenadine 60mg (Dose Level one) then a combination product of naproxen 440mg and fexofenadine 120mg (Dose Level Two). |
| Naproxen | Active comparator | Drug: Naproxen, Drug: placeboNaproxen 220mg or 440mg |
| Fexofenadine | Active comparator | Drug: Fexofenadine, Drug: placebofexofenadine 60mg or 120mg |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Healthy, non-smoking men or women between 21 and 65 years inclusive; 2. Good general health as determined by a thorough medical history and physical examination including vital signs; 3. Subject is a self-reported moderate drinker of alcohol, typically 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 120-160 pound female drinking 2 to 5 drinks in 2 to 3 hours, respectively, and a 160-200 pound male drinking 3 to 7 drinks in 2 to 3 hours, respectively; 4. Subject has prequalified as likely hangover-sensitive based on pre-study questionnaire; 5. Body mass index between 19 and 32 kg/m2, inclusive ; 6. Report a regular, habitual bedtime between 21:30 and 24:00; 7. Females of childbearing potential must have a negative urine pregnancy test at screening and upon admission for each treatment visit and be using an acceptable method of contraception (see Section 8.5); 8. Subject is capable of understanding the requirements of the study and to give written informed consent; 9. Subject is able to follow study instructions and is willing to complete all study visits and procedures.
- -
Key exclusion criteria (2 listed)
- 1. Acute illness within 14 days prior to screening visit; 2. Allergic reaction or upper respiratory tract infection within 7 days of screening visit; 3. Vaccination administration within 7 days of screening visit; 4. Clinically significant, unstable medical illness; 5. Evidence or history of clinically significant autoimmune, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease; 6. History of cancer or diabetes; 7. Subject has a previous or current Substance-Related Disorder as defined by DSM 5; 8. A score of 8 or greater on the AUDIT scale; 9. 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); 10. Positive alcohol Breathalyzer test at check-in for any treatment visit; 11. Positive urine drug screen at screening or at check-in for any treatment visit; 12. A seated blood pressure > 140/90 mm/Hg at screening; 13. Heart rate > 100 beats per minute at screening; 14. 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; 15. Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition; 16. Any clinically significant abnormal finding on physical examination or vital signs; 17. Subject has previously experienced an allergic reaction or adverse event associated with aspirin, NSAIDs, or antihistamine usage; 18. Subject requires the use of any prescription or over-the-counter (OTC) oral pain medication(s) on study treatment days; 19. Women who are breastfeeding; 20. 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; 21. Concurrent participation in an investigational drug or device study, or use of any investigational drug within 30 days prior to screening.
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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 |
|---|---|---|
| JMI-001JMI-001, a combination product of naproxen and fexofenadine | Drug | JMI-001 |
| NaproxenNaproxen sodium 220mg | Drug | Naproxen |
| FexofenadineFexofenadine 60mg | Drug | Fexofenadine |
| placeboplacebo comparator | Drug | Fexofenadine, Naproxen, Placebo |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 24 hours
Maximum Plasma Concentration of each drug measured in ng/mL
Time to Maximum Plasma Concentration (Tmax)
Time frame: 24 hours
Time to achieve the (Cmax) for each drug measured in hours
Area Under the Curve (AUC)
Time frame: 24 hours
Area Under the Curve for each drug measured in h*ng/mL
Elimination half-life
Time frame: 24 hours
Elimination half-life measured in hours
2 secondary outcomes
Hangover Severity Score
Time frame: 24 hours
Multiple Symptom Hangover Severity Score
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Veisalgia
Not yet recruitingPhase 2
Rapid BAC Reduction with Nutraceutical Blend Study
Alcohol Consumption, Alcohol
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.
Magdy L Shenouda, MD principal investigator
Clinilabs, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMI-001, Naproxen and Fexofenadine in people with Veisalgia, run by Sen-Jam Pharmaceutical.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Cassidy (646-215-6400, mcassidy@clinilabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2017.