Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00527150

Purpose

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.

Condition	Intervention	Phase
Smoking Cessation	Drug: Varenicline Tartrate	Phase I

MedlinePlus related topics: Quitting Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Pharmacokinetic endpoints include varenicline area under the curve from 0-24 hours (AUC24), maximum plasma concentration (Cmax), [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Time of maximum plasma concentration (Tmax) on Day 1 and Day 14 [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	October 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1 Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).	Drug: Varenicline Tartrate Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.
Cohort 2 Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).	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.
Cohort 3 Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).	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.
Optional Cohort 4 Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).	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.
Optional Cohort 5 Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).	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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527150

Locations

United States, Minnesota
Pfizer Investigational Site
East Grand Forks, Minnesota, United States, 58721
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051069
Study First Received:	September 6, 2007
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00527150 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Smoking
Varenicline

ClinicalTrials.gov processed this record on May 07, 2009