Healthy SmokersPhase 1NCT01574898
Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations
A Phase 1 study testing V0474 - A mg, V0474 - B mg and V0474 - C mg in people with Healthy Smokers, run by Pierre Fabre Medicament at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Smokers
- What is being tested?
- V0474 - A mg, V0474 - B mg and V0474 - C mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Healthy Smokers
- Being tested
- V0474 - A mg, V0474 - B mg, V0474 - C mg, V0018 - B mg, Niquitin® Fresh Mint 4 mg
- Keywords
- Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0474 - A mgDrug
Single oral administration
V0474 - B mgDrug
Single oral administration
V0474 - C mgDrug
Single oral administration
V0018 - B mgDrug
Single oral administration
Niquitin® Fresh Mint 4 mgDrug
Single oral administration
| Study group | Role | What they receive |
|---|---|---|
| Niquitin® Fresh Mint 4 mg | Active comparator | Not described Receives: Drug: Niquitin® Fresh Mint 4 mg |
| V0118 - B mg | Active comparator | Not described Receives: Drug: V0018 - B mg |
| V0474 - C mg | Experimental | Not described Receives: Drug: V0474 - C mg |
| V0474 - B mg | Experimental | Not described Receives: Drug: V0474 - B mg |
| V0474 - A mg | Experimental | Not described Receives: Drug: V0474 - A mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 time points up to 6h after oral administration
Secondary outcomes (2)
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.
Measured: Screening up to Day 5
Acceptability questionnaire
Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time
Measured: Up to complete lozenge dissolution, about 30 minutes (4 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574898
- Sponsor's protocol ID
- V00474 PC 1 01
- Other IDs
- 2012-000419-94
- Status last verified
- Jul 2012
- First submitted
- 2 Apr 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01574898
- Acronym / sponsor ID
- V00474 PC 1 01
- Conditions
- Healthy Smokers
- Keywords
- Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V0474 - A mgSingle oral administration | Drug | V0474 - A mg |
| V0474 - B mgSingle oral administration | Drug | V0474 - B mg |
| V0474 - C mgSingle oral administration | Drug | V0474 - C mg |
| V0018 - B mgSingle oral administration | Drug | V0118 - B mg |
| Niquitin® Fresh Mint 4 mgSingle oral administration | Drug | Niquitin® Fresh Mint 4 mg |
Primary outcome
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
2 secondary outcomes
Clinical safety (reported adverse events)
Time frame: Screening up to Day 5
Acceptability questionnaire
Time frame: Up to complete lozenge dissolution, about 30 minutes (4 times)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V0474 - A mg, V0474 - B mg and V0474 - C mg in people with Healthy Smokers, run by Pierre Fabre Medicament at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.