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A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days

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NCT01234142

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Fargo, North Dakota, 58104 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy

- male or female

- adult cigarette smokers of any race

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, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Subjects with active suicidal ideation or suicidal behavior within 1 year prior to
Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity
Rating Scale) or active ideation identified at Screening or Day 0.

- Any condition possibly affecting drug absorption through the skin (eg, psoriasis).

NCT01234142
Pfizer
Completed
A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days

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A Study Evaluating the Absorption Of Varenicline Through The Skin Following Once Daily Application Of A Patch For 14 Days
A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Cohort, Escalating Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of A Varenicline Transdermal Delivery System In Adult Smokers
This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Smoking Cessation
  • Drug: varenicline free base patch
    varenicline transdermal delivery system (12.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
  • Drug: varenicline free base patch
    varenicline transdermal delivery system (18.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
  • Drug: placebo patch
    Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
  • Drug: varenicline free base patch
    varenicline transdermal delivery system (24.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
  • Drug: varenicline free base patch
    2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days
  • Drug: placebo patch
    Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days
  • Experimental: Cohort 1
    Intervention: Drug: varenicline free base patch
  • Experimental: Cohort 2
    Interventions:
    • Drug: varenicline free base patch
    • Drug: placebo patch
  • Experimental: Cohort 3
    Interventions:
    • Drug: varenicline free base patch
    • Drug: placebo patch
  • Experimental: Cohort 4
    Interventions:
    • Drug: varenicline free base patch
    • Drug: placebo patch
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy
  • male or female
  • adult cigarette smokers of any race

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subjects with active suicidal ideation or suicidal behavior within 1 year prior to Screening as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or active ideation identified at Screening or Day 0.
  • Any condition possibly affecting drug absorption through the skin (eg, psoriasis).
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01234142
A3051142
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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