Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations

Phase 1

Completed

• Conditions: Healthy Smokers
• Interventions: Drug: Niquitin® Fresh Mint 4 mg; Drug: V0018 - B mg; Drug: V0474 - C mg; Drug: V0474 - B mg; Drug: V0474 - A mg

• Registration Number: NCT01574898
• Lead Sponsor: Pierre Fabre Medicament

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Niquitin® Fresh Mint 4 mg	Niquitin® Fresh Mint 4 mg	-
V0118 - B mg	V0018 - B mg	-
V0474 - C mg	V0474 - C mg	-
V0474 - B mg	V0474 - B mg	-
V0474 - A mg	V0474 - A mg	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers	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

Name	Time	Method
Clinical safety (reported adverse events)	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.
Acceptability questionnaire	Up to complete lozenge dissolution, about 30 minutes (4 times)	Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gieres, France