- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01478230
An Exploratory Study Comparing Two Nicotine Inhalers
A Proof of Concept With a New Nicotine Inhaler in Comparison With Nicotine Inhaler 10 mg
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Blood for pharmacokinetic analyses will be drawn prior to the first administration and immediately before administration at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 hours. Thereafter samples will be drawn at 5, 10, 15, 20, 25, 30, 45, and 60 minutes after the 11-hour administration. Easiness of use will be rated using an 8-grade ordered category scale at 10 minutes after the start of administrations at 3, 6, and 9 hours. Overall liking will be rated using an 8-grade ordered category scale at 12 hours. Urges to smoke will be rated on a 4-grade ordered category scale immediately before and at 15 minutes after the first administration, and as well as before and 15 minutes after the start of administrations at 3, 6, and 9 hours, and at 12 hours. Used cartridges will be collected. Pooled samples per subject and treatment will be analyzed to determine the amount of remaining nicotine. Tolerability of the treatments will be evaluated in terms of reported and observed adverse events (AE).
Since the primary objective is to compare steady-state nicotine pharmacokinetics of N1/3-I5 with that of Nicotine Inhaler 10 mg, this study will have a multiple-dose setting. A crossover design has been chosen for this study in order to allow within-subject comparisons of treatments. Healthy habituated adults smoking at least 10 cigarettes daily for at least one year preceding inclusion will be included in the study, since they are expected to tolerate the doses of nicotine that will be administered.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Lund, Sverige, 222 20
- McNeil AB Clinical Pharmacology R&D
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy (per protocol-specified parameters) male or female subjects between the ages of 19 and 50 years, inclusive.
- Smoking of at least 10 cigarettes daily during at least one year preceding inclusion.
- For females: Postmenopausal state or premenopausal/perimenopausal state with a protocol-specified effective means of contraception or declared absence of sexual contact with a male partner during the study.
- For males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
- Body Mass Index (BMI) within protocol-specified parameters.
- A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol
Exclusion Criteria:
- Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the investigator or an authorized study physician, may increase the risk associated with study participation or interfere with the interpretability of study results.
- Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria.
- Males: Pregnant spouse or partner or no willingness to prevent conception in a spouse or partner.
- History of regular alcohol consumption outside the protocol-specified allowances.
- Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
- Known sensitivity to heparin or history of heparin-induced thrombocytopenia.
- Pathological oral status interfering with normal muscular, sensory, or absorptive function of the oral cavity. Piercing of tongue and lips is considered to impair oral function.
- Relationship to persons involved directly with the conduct of the study, or their families.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: N1/3-I5
5 mg Inhalation during 10 minutes every hour for 11 hours with a puff frequency of four puffs per minute, with a 36-hour washout between visits
|
Nicotine 5 mg Inhaler
Andre navne:
Nicotine 10 mg Inhaler
Andre navne:
|
Aktiv komparator: NX-I10
10 mg Inhalation during 10 minutes every hour for 11 hours with a puff frequency of four puffs per minute, with a 36-hour washout between visits.
|
Nicotine 5 mg Inhaler
Andre navne:
Nicotine 10 mg Inhaler
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: During last dosing interval 11-12 hours post-dose
|
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
|
During last dosing interval 11-12 hours post-dose
|
Average Concentration (Cav)
Tidsramme: During last dosing interval 11-12 hours post-dose
|
The average concentration of nicotine in the blood. * The dosing interval (τ) in this study will be one (1) hour. Consequently, Cav will have the same value as AUCτ (but with a different unit), since Cav is calculated as AUCτ divided by τ. Therefore Cav will not be displayed in results, only AUCτ. |
During last dosing interval 11-12 hours post-dose
|
Bioavailability [AUCτ]
Tidsramme: During last dosing interval 11-12 hours post-dose
|
AUCτ is the area under the plasma concentration-vs.-time
curve during the last dosing interval and is a measure of how much of the drug reaches the person's bloodstream.
The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period.
The area under this curve is calculated as hour * nanograms (ng) per milliliter (mL).
|
During last dosing interval 11-12 hours post-dose
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Minimum Observed Plasma Concentration (Cmin)
Tidsramme: During last dosing interval 11-12 hours post-dose
|
Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
|
During last dosing interval 11-12 hours post-dose
|
Time of Maximum Concentration (Tmax)
Tidsramme: During last dosing interval 11-12 hours post-dose
|
The time at which maximum concentration is reached (Tmax)
|
During last dosing interval 11-12 hours post-dose
|
Peak Trough Fluctuation (PTF)
Tidsramme: During last dosing interval 11-12 hours post-dose
|
Peak trough fluctuation within one dosing interval at steady state.
|
During last dosing interval 11-12 hours post-dose
|
Swing
Tidsramme: During last dosing interval 11-12 hours post-dose
|
Swing within one dosing interval at steady state.
|
During last dosing interval 11-12 hours post-dose
|
Baseline-corrected Pre-Dosing Plasma Concentration (Cn)
Tidsramme: 0 Minutes
|
Baseline-corrected nicotine plasma concentrations immediately before each user session (Cn)
|
0 Minutes
|
Residual Nicotine
Tidsramme: 12 hours
|
Used cartridges will be collected.
Pooled samples per subject and treatment will be analyzed to determine the amount of remaining nicotine.
|
12 hours
|
Urges to Smoke
Tidsramme: During 12 hours
|
Subjects will rate their urges to smoke on a category scale from 1 to 4, where 1= No or very light urge to smoke, and 4= Very strong or extreme urge to smoke.
|
During 12 hours
|
Overall Liking
Tidsramme: at 12 hours
|
Overall Liking will be rated on a category scale from 1 to 8, where 1= extremely good and 8=extremely bad.
|
at 12 hours
|
Ease of Use
Tidsramme: During 9 hours
|
Ease of use will be rated at specific categorical time points, on a scale of 1-8, where 1= extremely easy and 8=extremely hard..
|
During 9 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Stof-relaterede lidelser
- Tobaksbrugsforstyrrelse
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Ganglionstimulerende midler
- Nikotiniske agonister
- Kolinerge agonister
- Nikotin
Andre undersøgelses-id-numre
- NICTDP0002
- 2011-002796-41 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Nicotine
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Aktiv, ikke rekrutterende