Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oromucosal Nicotine · 1 trial · 1 indication
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)...
Oromucosal Nicotine is an investigational small molecule being studied as a nicotine replacement product. It is intended for use in healthy smokers, with a completed Phase 1 trial assessing its pharmacokinetics, tolerability, and safety in healthy Japanese smokers.
Oromucosal Nicotine is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company conducted a Phase 1 clinical trial of the product in Japan.
Oromucosal Nicotine is in Phase 1 clinical development. It is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
Oromucosal Nicotine has one completed clinical trial, NCT03398876, titled 'A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers.' This Phase 1 study enrolled 24 healthy participants in Japan.
Oromucosal Nicotine is a nicotine replacement product, but it is not the same as other marketed nicotine replacement therapies. It is a new oral formulation under investigation, and its specific composition and delivery method are distinct from existing products.