Completed
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
What is being tested
NIC7-001
+ NIC7-003
+ Saline
Biological
Who is being recruted
Behavior+1
+ Health Behavior
+ Smoking
From 18 to 60 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 1
Interventional
Study Start: June 2012
Summary
Principal SponsorPfizer
Last updated: January 26, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorPfizer
Last updated: January 26, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
277 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorHealth BehaviorSmokingSmoking Cessation
Criteria
3 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
Active suicidal ideation or history of suicidal behaviors within the past 5 years prior to the screening visit
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalIntramuscular, multiple dose
Group III
PlaceboIntramuscular
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Diex Research Montreal, Inc.
Montreal, CanadaDiex Research Sherbrooke Inc.
Sherbrooke, CanadaCompleted3 Study Centers