NCT01574898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

April 2, 2012

Last Update Submit

July 6, 2012

Conditions

Healthy Smokers

Keywords

Smoking cessationNicotineTobacco Use DisorderCentral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Clinical safety (reported adverse events)

    Screening up to Day 5

  • Acceptability questionnaire

    Up to complete lozenge dissolution, about 30 minutes (4 times)

Study Arms (5)

Niquitin® Fresh Mint 4 mg

ACTIVE COMPARATOR
Drug: Niquitin® Fresh Mint 4 mg

V0118 - B mg

ACTIVE COMPARATOR
Drug: V0018 - B mg

V0474 - C mg

EXPERIMENTAL
Drug: V0474 - C mg

V0474 - B mg

EXPERIMENTAL
Drug: V0474 - B mg

V0474 - A mg

EXPERIMENTAL
Drug: V0474 - A mg

Interventions

V0474 - A mgDRUG

Single oral administration

V0474 - A mg
V0474 - B mgDRUG

Single oral administration

V0474 - B mg
V0474 - C mgDRUG

Single oral administration

V0474 - C mg
V0018 - B mgDRUG

Single oral administration

V0118 - B mg
Niquitin® Fresh Mint 4 mgDRUG

Single oral administration

Niquitin® Fresh Mint 4 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofins Optimed

Gières, France

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2012

First Posted

April 10, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

FR(1)