Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

Back to Search
Print
Bookmark Trial

NCT00527150

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
East Grand Forks, Minnesota, 58721, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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 and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.

- Currently smoking and have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 continuous 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, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).


- Pregnant or nursing women are excluded; women of childbearing potential (WOCBP) who
are unwilling or unable to use an acceptable method of contraception as outlined in
the protocol from at least 14 days prior to study medication administration until
completion of protocol-required procedures are excluded.


- Subjects with an estimated creatinine clearance (CLcr) <80 mL/min derived using the
method of Cockcroft and Gault.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Smoking CessationVarenicline Observational Investigation In The Cessation of Smoking
NCT00669240
  1. Alleur,
  2. Beerse,
  3. Braine le Comte,
  4. Bruxelles,
  5. Bruxelles,
  6. Bruxelles,
  7. Deinze,
  8. Edegem,
  9. Genk,
  10. Gent,
  11. Habay-la-Neuve,
  12. Halen,
  13. Jette,
  14. Kortessem,
  15. Leuven,
  16. Libramont-Chevigny,
  17. Liege,
  18. Moerkerke,
  19. Monceau-sur-Sambre,
  20. Moorsel,
  21. Namur,
  22. Rijkevorsel,
  23. Vedrin,
  24. Vilvoorde,
  25. Yvoir,
  26. Zedelgem,
  27. Holargos, Athens
  28. Ilisia, Athens
  29. Marousi, Athens
  30. Herakleion, Crete
  31. Exohi, Thessaloniki
  32. Alexandroupoli,
  33. Ioannina,
  34. Kavala,
  35. Larissa,
  36. Thessaloniki,
  37. Budapest,
  38. Budapest,
  39. Eger,
  40. Erd,
  41. Farkasgyepu,
  42. Hatvan,
  43. Nyiregyhaza,
  44. Siofok,
  45. Szombathely,
  46. Zalaegerszeg,
  47. Cerknica,
  48. Domzale,
  49. Jesenice,
  50. Kranj,
  51. Ljubljana,
  52. Maribor,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Smoking CessationA Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers
NCT00463918
  1. Anniston, Alabama
  2. Anniston, Alabama
  3. Phoenix, Arizona
  4. Hot Springs, Arkansas
  5. Anaheim, California
  6. Los Angeles, California
  7. New Haven, Connecticut
  8. DeLand, Florida
  9. Gainesville, Florida
  10. Honolulu, Hawaii
  11. Honolulu, Hawaii
  12. Overland Park, Kansas
  13. Bardstown, Kentucky
  14. Lexington, Kentucky
  15. San Antonio, Texas
  16. Slough, Berkshire
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Smoking CessationSmoking Cessation Study In Healthy Adolescent Smokers
NCT01312909
  1. Ozark, Alabama
  2. Goodyear, Arizona
  3. Little Rock, Arkansas
  4. Anaheim, California
  5. La Habra, California
  6. National City, California
  7. Oakland, California
  8. Oceanside, California
  9. Aurora, Colorado
  10. Colorado Springs, Colorado
  11. Denver, Colorado
  12. New Haven, Connecticut
  13. New Haven, Connecticut
  14. New Haven, Connecticut
  15. DeLand, Florida
  16. Kissimmee, Florida
  17. Maitland, Florida
  18. Miami, Florida
  19. Miami, Florida
  20. North Bay Village, Florida
  21. Orange City, Florida
  22. Saint Petersburg, Florida
  23. Meridian, Idaho
  24. Meridian, Idaho
  25. Evansville, Indiana
  26. Indianapolis, Indiana
  27. Newburgh, Indiana
  28. Wichita, Kansas
  29. Bardstown, Kentucky
  30. Lexington, Kentucky
  31. Owensboro, Kentucky
  32. Owensboro, Kentucky
  33. New Orleans, Louisiana
  34. Watertown, Massachusetts
  35. Rochester Hills, Michigan
  36. Kansas City, Missouri
  37. O'Fallon, Missouri
  38. Saint Louis, Missouri
  39. Lincoln, Nebraska
  40. Raleigh, North Carolina
  41. Raleigh, North Carolina
  42. Wilmington, North Carolina
  43. Canton, Ohio
  44. Toledo, Ohio
  45. Oklahoma City, Oklahoma
  46. Charleston, South Carolina
  47. Mount Pleasant, South Carolina
  48. Dallas, Texas
  49. DeSoto, Texas
  50. Lake Jackson, Texas
  51. San Antonio, Texas
  52. San Antonio, Texas
  53. Richmond, Virginia
  54. Kirkland, Washington
  55. Richland, Washington
  56. Middleton, Wisconsin
  57. Ajax, Ontario
  58. New Market, Ontario
  59. Newmarket, Ontario
  60. Rustavi,
  61. Anyang-si, Gyeonggi-do
  62. Seongnam-si, Gyeonggi-do
  63. Suwon-si, Gyeonggi-do
  64. Daegu,
  65. Village Novoe Devyatkino, Leningrad Region
  66. Moscow,
  67. Murmansk,
  68. Novosibirsk,
  69. Saint-Petersburg,
  70. Saint-Petersburg,
  71. Saint-Petersburg,
  72. Saint-Petersburg,
  73. Saint-Petersburg,
  74. Samara,
  75. Kaohsiung City,
  76. New Taipei City,
  77. New Taipei City,
  78. Taichung city,
  79. Tainan,
  80. Taipei City,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Smoking CessationA Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
NCT00150241
  1. Los Angeles, California
  2. Farmington, Connecticut
  3. Minneapolis, Minnesota
  4. Omaha, Nebraska
  5. New York, New York
  6. Portland, Oregon
  7. Morgantown, West Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers
Official Title  ICMJE A Phase 1, Investigator And Subject Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Varenicline Amt-8 Controlled Release Formulation In Adult Smokers
Brief Summary The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple oral doses of varenicline AMT 8 controlled release formulation for 14 days in adult smokers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Varenicline Tartrate
    Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.
  • Drug: Varenicline Tartrate
    Planned dose is Varenicline 2.4 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
  • Drug: Varenicline Tartrate
    Planned dose is Varenicline 3 mg AMT-8 controlled release tablets administered twice a day for 14 days. Actual dose may be adjusted based on emerging data from prior dose cohorts.
  • Drug: Varenicline Tartrate
    The dose to be administered is not yet determined and will be based on emerging data from prior dose cohorts. The dose will be administered as Varenicline AMT-8 controlled release tablets twice a day for 14 days. The doses to be tested may be lower, higher or repeat a previously tested dose and may include a titration.
Study Arms  ICMJE
  • Cohort 1
    Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
    Intervention: Drug: Varenicline Tartrate
  • Cohort 2
    Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
    Intervention: Drug: Varenicline Tartrate
  • Cohort 3
    Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
    Intervention: Drug: Varenicline Tartrate
  • Optional Cohort 4
    Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
    Intervention: Drug: Varenicline Tartrate
  • Optional Cohort 5
    Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
    Intervention: Drug: Varenicline Tartrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2008)		48
Original Enrollment  ICMJE
 (submitted: September 7, 2007)		60
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
  • Currently smoking and have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 continuous months in the past year.

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).
  • Pregnant or nursing women are excluded; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to study medication administration until completion of protocol-required procedures are excluded.
  • Subjects with an estimated creatinine clearance (CLcr) <80 mL/min derived using the method of Cockcroft and Gault.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00527150
Other Study ID Numbers  ICMJE A3051069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP