A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.

Pfizer

Status and phase

Completed

Phase 1

Conditions

Vaccines

Smoking

Treatments

Biological: NIC7-003

Biological: NIC7-001

Biological: Saline

Study type

Interventional

Funder types

Industry

Identifiers

B3771001

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of multiple doses of PF-05402536 and PF-06413367 in healthy adult smokers.

Enrollment

277 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Current cigarette smokers
Males or females of non-child bearing potential, who are between the minimum legal age for smoking (approximately 18 or 19 years, depending on local jurisdiction) and 55 years, inclusive, and who are motivated to stop smoking.
Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the prescreening assessment for entry, with no period of abstinence greater than 3 months in the past year.

Exclusion criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or neurologic disease that may compromise their ability to safely participate in the study.
Active suicidal ideation or history of suicidal behaviors within the past 5 years prior to the screening visit.