Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

• ClinicalTrials.gov Identifier: NCT01574898
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Last Update Posted: July 10, 2012
• Sponsor: Pierre Fabre Medicament
• Information provided by (Responsible Party): Pierre Fabre Medicament

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy Smokers	Drug: V0474 - A mg; Drug: V0474 - B mg; Drug: V0474 - C mg; Drug: V0018 - B mg; Drug: Niquitin® Fresh Mint 4 mg	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: March 2012
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Niquitin® Fresh Mint 4 mg	Drug: Niquitin® Fresh Mint 4 mg; Single oral administration
Active Comparator: V0118 - B mg	Drug: V0018 - B mg; Single oral administration
Experimental: V0474 - C mg	Drug: V0474 - C mg; Single oral administration
Experimental: V0474 - B mg	Drug: V0474 - B mg; Single oral administration
Experimental: V0474 - A mg	Drug: V0474 - A mg; Single oral administration

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers [ Time Frame: 12 time points up to 6h after oral administration ]
   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

Secondary Outcome Measures :

1. Clinical safety (reported adverse events) [ Time Frame: Screening up to Day 5 ]
   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.
2. Acceptability questionnaire [ Time Frame: Up to complete lozenge dissolution, about 30 minutes (4 times) ]
   Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

France

Eurofins Optimed

Gieres, France

Sponsors and Collaborators

Pierre Fabre Medicament

More Information

• Responsible Party: Pierre Fabre Medicament
• ClinicalTrials.gov Identifier: NCT01574898
• Other Study ID Numbers: V00474 PC 1 01; 2012-000419-94 ( EudraCT Number )
• First Posted: April 10, 2012
• Last Update Posted: July 10, 2012
• Last Verified: July 2012

Keywords provided by Pierre Fabre Medicament:

Smoking cessation; Nicotine; Tobacco Use Disorder; Central Nervous System Agents