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

Phase 1

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline Tartrate

• Registration Number: NCT00527150
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Study Start: 2007-10
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-07
• Last Update Posted: 2010-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Varenicline Tartrate	Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Cohort 2	Varenicline Tartrate	Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Cohort 3	Varenicline Tartrate	Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Optional Cohort 4	Varenicline Tartrate	Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).
Optional Cohort 5	Varenicline Tartrate	Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic endpoints include varenicline area under the curve from 0-24 hours (AUC24), maximum plasma concentration (Cmax),	Day 1 and Day 14
Safety endpoints include evaluation of clinical safety laboratory tests, supine vital signs, triplicate 12-lead ECGs and adverse events.	up to 14 days
Time of maximum plasma concentration (Tmax) on Day 1 and Day 14	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.	Day 14

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Fargo, North Dakota, United States