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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Vaccines
• Intervention / Treatment: Biological: NIC7-001; Biological: NIC7-003; Biological: Saline

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 2T3
      • INC Research Toronto Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2Y 1S1
      • Diex Research Montreal, Inc.
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PF-05402536	Biological: NIC7-001; Intramuscular, multiple dose
EXPERIMENTAL: PF-06413367; Intramuscular, multiple dose	Biological: NIC7-003; Intramuscular, multiple dose
PLACEBO_COMPARATOR: Placebo; Intramuscular	Biological: Saline; Saline (0.9% sodium chloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibody titers against nicotine.	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
smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges)	Up to Day 364

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (ESTIMATE): August 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: vaccine; Phase 1; Smoking cessation
• Other Study ID Numbers: B3771001