Status:
COMPLETED
An Exploratory Study Comparing Two Nicotine Inhalers
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
19-50 years
Phase:
EARLY_PHASE1
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,...
Detailed Description
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 draw...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01478230
Start Date
November 1 2011
End Date
December 1 2011
Last Update
July 10 2012
Active Locations (1)
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1
McNeil AB Clinical Pharmacology R&D
Lund, Sweden, 222 20