NCT01672645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

3.5 years

First QC Date

July 5, 2012

Last Update Submit

January 25, 2016

Conditions

SmokingVaccines

Keywords

Smoking cessationvaccinePhase 1

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • 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

Study Arms (3)

PF-05402536

EXPERIMENTAL
Biological: NIC7-001

PF-06413367

EXPERIMENTAL

Intramuscular, multiple dose

Biological: NIC7-003

Placebo

PLACEBO COMPARATOR

Intramuscular

Biological: Saline

Interventions

NIC7-001BIOLOGICAL

Intramuscular, multiple dose

PF-05402536
NIC7-003BIOLOGICAL

Intramuscular, multiple dose

PF-06413367
SalineBIOLOGICAL

Saline (0.9% sodium chloride)

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

INC Research Toronto Inc.

Toronto, Ontario, M5V 2T3, Canada

Location

Diex Research Montreal, Inc.

Montreal, Quebec, H2Y 1S1, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Links

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

August 27, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

CA(3)