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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
INC Research Toronto Inc.
Toronto, Ontario, M5V 2T3 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking, Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01672645
Pfizer
Completed
A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Smoking
  • Vaccines
  • Biological: NIC7-001
    Intramuscular, multiple dose
  • Biological: NIC7-003
    Intramuscular, multiple dose
  • Biological: Saline
    Saline (0.9% sodium chloride)
  • Experimental: PF-05402536
    Intervention: Biological: NIC7-001
  • Experimental: PF-06413367
    Intramuscular, multiple dose
    Intervention: Biological: NIC7-003
  • Placebo Comparator: Placebo
    Intramuscular
    Intervention: Biological: Saline
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01672645
B3771001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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