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OpenTrials
Completed

NCT Number: NCT01672645

A Study to Assess the Safety and Tolerability of Different Doses 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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation Vaccines

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

INC Research Toronto Inc., Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIC7-001

Biological

Intramuscular, multiple dose

NIC7-003

Biological

Intramuscular, multiple dose

Saline

Biological

Saline (0.9% sodium chloride)

Primary outcomes

  1. 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

  2. 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

  3. Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment

    Time frame: Baseline up to Day 364

  4. Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment

    Time frame: Baseline up to Day 364

Secondary outcomes

  1. Antibody titers against nicotine.

    Time frame: Up to Day 364

  2. Avidity of antibodies against nicotine.

    Time frame: Up to Day 364

  3. 7-day point prevalence of smoking abstinence

    Time frame: Up to Day 364

  4. 4-week continuous abstinence rate from smoking

    Time frame: Up to Day 364

  5. smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges)

    Time frame: Up to Day 364

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2012
Registry last updated
Jan 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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