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

Sponsors

Lead Sponsor: Pfizer

Source 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.

Overall Status Completed
Start Date 2012-06-01
Completion Date 2015-12-01
Primary Completion Date 2015-12-01
Phase Phase 1
Study Type Interventional
Primary 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
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
Enrollment 277
Condition
Intervention

Intervention Type: Biological

Intervention Name: NIC7-001

Description: Intramuscular, multiple dose

Arm Group Label: PF-05402536

Intervention Type: Biological

Intervention Name: NIC7-003

Description: Intramuscular, multiple dose

Arm Group Label: PF-06413367

Intervention Type: Biological

Intervention Name: Saline

Description: Saline (0.9% sodium chloride)

Arm Group Label: Placebo

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility:
INC Research Toronto Inc. | Toronto, Ontario, M5V 2T3, Canada
Diex Research Montreal, Inc. | Montreal, Quebec, H2Y 1S1, Canada
Diex Research Sherbrooke Inc. | Sherbrooke, Quebec, J1H 1Z1, Canada
Location Countries

Canada

Verification Date

2016-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: PF-05402536

Type: Experimental

Label: PF-06413367

Type: Experimental

Description: Intramuscular, multiple dose

Label: Placebo

Type: Placebo Comparator

Description: Intramuscular

Study Design Info

Allocation: Randomized

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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