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

NCT00527150 | Completed Phase 1

• 1 other identifier: A3051069
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

Cohort 1

OTHER

Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).

Drug: Varenicline Tartrate

Cohort 2

OTHER

Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).

Drug: Varenicline Tartrate

Cohort 3

OTHER

Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).

Drug: Varenicline Tartrate

Optional Cohort 4

OTHER

Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).

Drug: Varenicline Tartrate

Optional Cohort 5

OTHER

Subjects will be randomized to receive either experimental drug (N=9) or matching placebo (N=3).

Drug: Varenicline Tartrate

Interventions

Varenicline Tartrate DRUG

Varenicline 1.8 mg AMT-8 controlled release tablets administered twice a day for 14 days.

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

East Grand Forks, Minnesota, 58721, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, 58104, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: January 11, 2010

Record last verified: 2010-01

Locations

US (2)