An Exploratory Study Comparing Two Nicotine Inhalers

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil AB
• Treatments: Nicotine

Criteria

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.