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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
East Grand Forks, Minnesota, 58721 United States
Contact
1-800-718-1021
ClinicalTrials.gov_Inq[email protected]
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) method of Cockcroft and Gault.

NCT00527150
Pfizer
Completed
Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

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Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00527150
A3051069
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

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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1-800-718-1021

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