Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03398876 | A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers | PHASE1 | COMPLETED | 24 | — | — | Dec 22, 2017 | Apr 16, 2018 | Feb 3, 2025 | 1 | Japan |
cCmax is defined as the maximum baseline corrected plasma nicotine concentration (cCmax).
cAUCt is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.
cAUC(infinity) is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve extrapolated to infinite.
cAUCt is defined as baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.
Cav is defined as the average plasma nicotine concentration during the last dosing interval/intervals.
AUCtau is defined as the area under the plasma nicotine concentration-vs time curve during the last dosing interval/intervals.
Cmax is defined as maximum observed plasma nicotine concentration.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Oromucosal Nicotine Spray (ONS) | DRUG | Participants will receive oral dose of oromucosal nicotine spray (ONS). |
| Nicotine Gum | DRUG | Participants will chew nicotine gum for 30 minutes. |
| Cigarette | OTHER | Participants will smoke one cigarette as 10 puffs for 3 minutes. |
Inclusion Criteria: * Healthy male or female Japanese participants between the ages of 20 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG)...