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

Smoking Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672645
• Other study ID #: B3771001
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2012
• Last updated: January 25, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Vaccines

Intervention

Biological:
• NIC7-001
Intramuscular, multiple dose
• NIC7-003
Intramuscular, multiple dose
• Saline
Saline (0.9% sodium chloride)

Locations

Country	Name	City	State
Canada	Diex Research Montreal, Inc.	Montreal	Quebec
Canada	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	INC Research Toronto Inc.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment		Baseline up to Day 364	Yes
Primary	Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment		Baseline up to Day 364	Yes
Secondary	Antibody titers against nicotine.		Up to Day 364	No
Secondary	Avidity of antibodies against nicotine.		Up to Day 364	No
Secondary	7-day point prevalence of smoking abstinence		Up to Day 364	No
Secondary	4-week continuous abstinence rate from smoking		Up to Day 364	No
Secondary	smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges)		Up to Day 364	No

External Links

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