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Nicotine Prototype Mini lozenge · 2 trials · 1 indication
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-inf). AUC(0-inf) = AUC0-t + (Clast/kel), where, AUC0-t= area under the plasma concentration versus time curve from time zero to time t; Clast= last observed/measured plasma concentration and kel= elimination rate constant. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC\[0-inf\]), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
Blood samples were collected at designated timepoints. Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring Cmax that was taken directly from bioanalytical data. Geometric Coefficient of variation was provided as percentage. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (Cmax) as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.
| Arm | Type | Description |
|---|---|---|
| Test Product | EXPERIMENTAL | Participants will receive a single Nicotine Prototype Mini lozenge (2mg) by oral/buccal route of administration. |
| Reference Product | ACTIVE_COMPARATOR | Participants will receive a single Nicorette Mini lozenge (2 mg) by oral/buccal route of administration. |
| Name | Type | Description |
|---|---|---|
| Nicotine Prototype Mini lozenge | DRUG | A single dose of a prototype nicotine 2mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved. |
| Nicorette Mini Lozenge | DRUG | A single dose of a 2 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved. |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Participants who are willing and able to comply with scheduled visits, treatment pl...
Nicotine Prototype Mini lozenge is being developed for tobacco use disorder. It is a small molecule nicotine lozenge intended as a smoking cessation aid, studied in healthy adult smokers. GSK plc is developing the product, and the clinical work completed so far has focused on comparing it with an existing nicotine lozenge reference product.
Nicotine Prototype Mini lozenge targets CHRNB2 and CHRNA4, which are nicotinic acetylcholine receptor subunits. The drug acts as an agonist at these receptors, mimicking the effect of nicotine. This receptor activity underlies its intended use in tobacco use disorder, where nicotine replacement helps reduce craving and withdrawal during quit attempts.
GSK plc, which trades under the ticker GSK, is the developer of Nicotine Prototype Mini lozenge. The company has run the clinical studies of the product to date, including two completed Phase 1 bioequivalence trials in healthy smokers in the United States.
Nicotine Prototype Mini lozenge is in Phase 1 development. Two Phase 1 trials have been completed, and no trials are currently active. The studies were randomized and actively controlled, with a total enrollment of 83 participants across the two completed trials.
Two completed Phase 1 trials have studied Nicotine Prototype Mini lozenge: NCT03543137, which assessed bioequivalence of the 4 mg prototype mini nicotine lozenge against the reference product Nicorette in healthy smokers, and NCT03541044, a bioequivalence study of two nicotine lozenges under fasting conditions. Both enrolled healthy adult smokers in the United States.