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| ID | Type | Description | Link |
|---|---|---|---|
| 10258820TDP1001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered repeated-dose administration in healthy Japanese smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1; Treatment Sequence ABDC | Experimental | Participants will receive Treatment A (one spray of oromucosal nicotine spray [ONS]) at Visit 1, then Treatment B (2 consecutive sprays of ONS at Visit 2, then Treatment D (1 cigarette [10 puffs]) at Visit 3, followed by Treatment C (nicotine gum) at Visit 4. The visits will be separated by a period of at least 7 calendar days. |
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| Part 1; Treatment Sequence BCAD | Experimental | Participants will receive Treatment B at Visit 1, then Treatment C at Visit 2, then Treatment A at Visit 3 followed by Treatment D at Visit 4. The visits will be separated by a period of at least 7 calendar days. |
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| Part 1; Treatment Sequence CDBA | Experimental | Participants will receive Treatment C at Visit 1, then Treatment D at Visit 2, then Treatment B at Visit 3 followed by Treatment A at Visit 4. The visits will be separated by a period of at least 7 calendar days. The visits will be separated by a period of at least 7 calendar days. |
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| Part 1; Treatment Sequence DACB | Experimental | Participants will receive Treatment D at Visit 1, then Treatment A at Visit 2, then Treatment C at Visit 3 followed by Treatment B at Visit 4. The visits will be separated by a period of at least 7 calendar days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oromucosal Nicotine Spray (ONS) | Drug | Participants will receive oral dose of oromucosal nicotine spray (ONS). |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Baseline Corrected Plasma Nicotine Concentration (cCmax) | cCmax is defined as the maximum baseline corrected plasma nicotine concentration (cCmax). | Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 minute (min) and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration versus (vs) Time Curve Until the Last Measurable Time Point (cAUCt) | cAUCt is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point. | Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration-vs Time Curve Extrapolated to Infinite (cAUC[infinity]) | cAUC(infinity) is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve extrapolated to infinite. | Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration-vs Time Curve until the Last Measurable Time Point (cAUCt) | cAUCt is defined as baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point. | Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part 2: Average Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cav) | Cav is defined as the average plasma nicotine concentration during the last dosing interval/intervals. | Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Plasma Nicotine Concentration-vs Time Curve until 10 Minutes after Start of Administration [AUC10min], | AUC10min is defined as the area under the plasma nicotine concentration-vs time curve until 10 minutes after start of administration. | Predose; 2, 4, 6, 8, 10 min postdose |
| Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai Hakata Clinic | Fukuoka | 8120025 | Japan |
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| Part 2; Treatment Sequence EF | Experimental | Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment E (two consecutive sprays of ONS once every 30 minutes until 11.5 hours) at Visit 5, followed by Treatment F (two consecutive sprays of ONS once every 1 hour until 11 hours) at Visit 6. The visits will be separated by a period of at least 7 calendar days. |
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| Part 2; Treatment Sequence FE | Experimental | Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment F at Visit 5 followed by Treatment E at Visit 6. The visits will be separated by a period of at least 7 calendar days. |
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| Nicotine Gum | Drug | Participants will chew nicotine gum for 30 minutes. |
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| Cigarette | Other | Participants will smoke one cigarette as 10 puffs for 3 minutes. |
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| Part 2: Area Under the Plasma Nicotine Concentration-vs Time Curve During the Last Dosing Interval/Intervals (AUCtau) | AUCtau is defined as the area under the plasma nicotine concentration-vs time curve during the last dosing interval/intervals. | Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F |
| Part 2: Maximum Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cmax) | Cmax is defined as maximum observed plasma nicotine concentration. | Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F |
Tmax is defined as actual sampling time to reach maximum observed analyte concentration. |
| Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part 1: Terminal Half-Life [t1/2] | Terminal half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part 1: Terminal Elimination Rate Constant (Lambda[z]) | Lambda (z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve. | Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Part 2: Minimum Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cmin) | Cmin is defined as the minimum plasma nicotine concentration during the last dosing interval/intervals. | Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F |
| Part 2: Peak-Trough Fluctuation [PTF] | PTF calculated by 100*(Cmax - Cmin)/Cav will be assessed. | Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F |
| Part 2: Swing | Swing will be calculated as (Cmax - Cmin)/Cmin. | Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F |
| Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F |
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Up to 4 months |
| ID | Term |
|---|---|
| D000074164 | Nicotine Chewing Gum |
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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