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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01672645
First received: July 5, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Smoking
Vaccines
Biological: NIC7-001
Biological: NIC7-003
Biological: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: Within 7 days after dose ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Within 7 days after dose ] [ Designated as safety issue: Yes ]
  • Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Baseline up to Day 364 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment [ Time Frame: Baseline up to Day 364 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody titers against nicotine. [ Time Frame: Up to Day 364 ] [ Designated as safety issue: No ]
  • Avidity of antibodies against nicotine. [ Time Frame: Up to Day 364 ] [ Designated as safety issue: No ]
  • 7-day point prevalence of smoking abstinence [ Time Frame: Up to Day 364 ] [ Designated as safety issue: No ]
  • 4-week continuous abstinence rate from smoking [ Time Frame: Up to Day 364 ] [ Designated as safety issue: No ]
  • smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges) [ Time Frame: Up to Day 364 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672645

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Canada, Ontario
Pfizer Investigational Site Recruiting
Toronto, Ontario, Canada, M5V 2T3
Canada, Quebec
Pfizer Investigational Site Recruiting
Montreal, Quebec, Canada, H4N 3C5
Pfizer Investigational Site Recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01672645     History of Changes
Other Study ID Numbers: B3771001
Study First Received: July 5, 2012
Last Updated: August 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
Smoking cessation
vaccine
Phase 1

ClinicalTrials.gov processed this record on August 21, 2014