Clinical trial NCT01672645: A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.
Official title: A Phase 1, Randomized, Double Blind, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Efficacy Of Multiple Ascending Dose Levels Of Pf-05402536 And Pf-06413367 In Healthy Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Vaccines
Keywords: Smoking cessation
vaccine
Phase 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-08-27
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of solicited local reactions (erythema, induration, and pain) and severity of the local reactions as self-reported on electronic diaries (e-diaries) for 7 days following vaccination.
timeFrame: Within 7 days after dose
measure: Frequency of solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and severity of solicited systemic events as self-reported on e-diaries for 7 days following vaccination.
timeFrame: Within 7 days after dose
measure: Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment
timeFrame: Baseline up to Day 364
measure: Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment
timeFrame: Baseline up to Day 364
Secondary outcomes:
measure: Antibody titers against nicotine.
timeFrame: Up to Day 364
measure: Avidity of antibodies against nicotine.
timeFrame: Up to Day 364
measure: 7-day point prevalence of smoking abstinence
timeFrame: Up to Day 364
measure: 4-week continuous abstinence rate from smoking
timeFrame: Up to Day 364
measure: smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges)
timeFrame: Up to Day 364
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INC Research Toronto Inc.
state: Ontario
city: Montreal
country: Canada
facility: Diex Research Montreal, Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: