An Exploratory Study Comparing Two Nicotine Inhalers

NCT01478230 | Completed Early Phase 1

• 2 other identifiers: NICTDP00022011-002796-41
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Dependence

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  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)

  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]

  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

Secondary Outcomes (9)

• Minimum Observed Plasma Concentration (Cmin)

  During last dosing interval 11-12 hours post-dose

• Time of Maximum Concentration (Tmax)

  During last dosing interval 11-12 hours post-dose

• Peak Trough Fluctuation (PTF)

  During last dosing interval 11-12 hours post-dose

• Swing

  During last dosing interval 11-12 hours post-dose

• Baseline-corrected Pre-Dosing Plasma Concentration (Cn)

  0 Minutes

Study Arms (2)

N1/3-I5

EXPERIMENTAL

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

Drug: Nicotine

NX-I10

ACTIVE COMPARATOR

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.

Drug: Nicotine

Interventions

Nicotine DRUG

Nicotine 5 mg Inhaler

Also known as: Not yet marketed

N1/3-I5

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (per protocol-specified parameters) male or female subjects between the ages of 19 and 50 years, inclusive.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

McNeil AB Clinical Pharmacology R&D

Lund, 222 20, Sweden

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

SE (1)