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

Phase 1

Completed

• Conditions: Smoking; Vaccines
• Interventions: Biological: NIC7-003; Biological: NIC7-001; Biological: Saline

• Registration Number: NCT01672645
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PF-06413367	NIC7-003	Intramuscular, multiple dose
PF-05402536	NIC7-001	-
Placebo	Saline	Intramuscular

Primary Outcome Measures

Name	Time	Method
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.	Within 7 days after dose
Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment	Baseline up to Day 364
Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment	Baseline up to Day 364
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.	Within 7 days after dose

Secondary Outcome Measures

Name	Time	Method
Antibody titers against nicotine.	Up to Day 364
smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges)	Up to Day 364
Avidity of antibodies against nicotine.	Up to Day 364
7-day point prevalence of smoking abstinence	Up to Day 364
4-week continuous abstinence rate from smoking	Up to Day 364

Trial Locations

Locations (3)

INC Research Toronto Inc.; 🇨🇦 Toronto, Ontario, Canada

Diex Research Montreal, Inc.; 🇨🇦 Montreal, Quebec, Canada

Diex Research Sherbrooke Inc.; 🇨🇦 Sherbrooke, Quebec, Canada