Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.

Official Title
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Pilot Pharmacokinetic Study of Three New Nicotine Lozenge Formulations (V0474) Versus Two Reference Formulations (V0018 B mg and Niquitin® Fresh Mint, 4mg) After Single Oral Administration in Healthy Male Smokers.

Conditions
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Healthy Smokers

Intervention / Treatment
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* Drug: V0474 - A mg
* Drug: V0474 - B mg
* Drug: V0474 - C mg
* Drug: V0018 - B mg
* Drug: Niquitin® Fresh Mint 4 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject aged 18 to 45 years (inclusive) Current smoker of < or = 10 cigarettes/day Fagerström score < or = 5 Absence of any clinically significant abnormal finding at physical, ECG, biological examinations in the Investigator's opinion Exclusion Criteria: Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer or oesophagitis) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator Current or recurrent buccal lesions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Niquitin® Fresh Mint 4 mg<br> | Drug: Niquitin® Fresh Mint 4 mg<br>* Single oral administration<br>|
| Active Comparator: V0118 - B mg<br> | Drug: V0018 - B mg<br>* Single oral administration<br>|
| Experimental: V0474 - C mg<br> | Drug: V0474 - C mg<br>* Single oral administration<br>|
| Experimental: V0474 - B mg<br> | Drug: V0474 - B mg<br>* Single oral administration<br>|
| Experimental: V0474 - A mg<br> | Drug: V0474 - A mg<br>* Single oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers | Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers by measuring Maximum Plasma Concentration (Cmax), Time of Maximum Concentration (Tmax) , Area under the nicotine plasma concentration curve (AUC0-t), for each test and reference formulations | 12 time points up to 6h after oral administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical safety (reported adverse events) | Safety by evaluating the number of subjects with emergent adverse events and changes from baseline to end of study in vital signs, Electrocardiogram (ECG) and clinical laboratory parameters. | Screening up to Day 5 | 
| Acceptability questionnaire | Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time | Up to complete lozenge dissolution, about 30 minutes (4 times) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents