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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Drug: Varenicline Tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527150

A3051069

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 5 patient groups

Cohort 1

Other group

Description:

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

Treatment:

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Cohort 2

Other group

Description:

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

Treatment:

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Cohort 3

Other group

Description:

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

Treatment:

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Optional Cohort 4

Other group

Description:

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

Treatment:

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Optional Cohort 5

Other group

Description:

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

Treatment:

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate

Drug: Varenicline Tartrate