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An Exploratory Study Comparing Two Nicotine Inhalers

6. juli 2012 oppdatert av: McNeil AB

A Proof of Concept With a New Nicotine Inhaler in Comparison With Nicotine Inhaler 10 mg

Subjects will be screened within 28 days before the first study treatment to confirm that they meet the requirements to participate in the trial. They will return to the site for two treatment visits, at least 12 hours each, and at least one day in between visits. At each visit treatment N1/3-I5 or Nicotine Inhaler 10 mg will be administered every hour for 11 hours. The investigator (or an appropriate delegate at the investigator site) will obtain informed consent from each subject. Blood samples will be drawn on a special schedule. The total predicted amount of blood sampled from each subject is 174 mL over the whole study. Subjects will be required to follow specific smoking and dietary restrictions and rate their urges to smoke, general liking of the product, and how easy the product is to use.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

36

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
      • Lund, Sverige, 222 20
        • McNeil AB Clinical Pharmacology R&D

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: Nicotine
Nicotine 5 mg Inhaler
Andre navn:
  • Ikke markedsført ennå
Legemiddel: Nicotine
Nicotine 10 mg Inhaler
Andre navn:
  • Ikke markedsført ennå
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.
Legemiddel: Nicotine
Nicotine 5 mg Inhaler
Andre navn:
  • Ikke markedsført ennå
Legemiddel: Nicotine
Nicotine 10 mg Inhaler
Andre navn:
  • Ikke markedsført ennå

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

McNeil AB

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2011

Primær fullføring (Faktiske)

1. desember 2011

Studiet fullført (Faktiske)

1. desember 2011

Datoer for studieregistrering

Først innsendt

21. november 2011

Først innsendt som oppfylte QC-kriteriene

21. november 2011

Først lagt ut (Anslag)

23. november 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. juli 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juli 2012

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NICTDP0002
  • 2011-002796-41 (EudraCT-nummer)

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