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Trial record 1 of 1 for:    NCT00527150
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Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

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ClinicalTrials.gov Identifier: NCT00527150
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 6, 2007
First Posted Date  ICMJE September 10, 2007
Last Update Posted Date January 11, 2010
Study Start Date  ICMJE October 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
  • Pharmacokinetic endpoints include varenicline area under the curve from 0-24 hours (AUC24), maximum plasma concentration (Cmax), [ Time Frame: Day 1 and Day 14 ]
  • Safety endpoints include evaluation of clinical safety laboratory tests, supine vital signs, triplicate 12-lead ECGs and adverse events. [ Time Frame: up to 14 days ]
  • Time of maximum plasma concentration (Tmax) on Day 1 and Day 14 [ Time Frame: Day 1 and Day 14 ]
  • Minimum plasma concentration (Cmin), terminal half life (t1/2), observed accumulation ratio (Rac), peak:trough fluctuation (%PTF) on Day 14 only. [ Time Frame: Day 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2007)
  • Pharmacokinetic endpoints include varenicline area under the curve from 0-24 hours (AUC24), maximum plasma concentration (Cmax), and time of maximum plasma concentration (Tmax) on Day 1 and Day 14
  • Minimum plasma concentration (Cmin), terminal half life (t1/2), observed accumulation ratio (Rac), and peak:trough fluctuation (%PTF) on Day 14 only
  • Safety endpoints include evaluation of clinical safety laboratory tests, supine vital signs, triplicate 12-lead ECGs and adverse events
Change History Complete list of historical versions of study NCT00527150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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