Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

Study Description

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Brief Summary:

This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.

Condition or disease	Intervention/treatment	Phase
Smoking	Drug: varenicline tartrate	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	14 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers
Study Start Date :	March 2007
Actual Study Completion Date :	March 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.

Secondary Outcome Measures :

1. To gather safety data from Day 0 to Day 17 of the study.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Healthy male and/or female Chinese subjects between the ages of 18 and 45 years, inclusive.
• Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg.
• Individuals who have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

• Heart rate>100 bpm, QRS Interval>120 msec, QTc Interval >430 msec, PR Interval>220 msec, or any other abnormalities observed on the Electrocardiogram.
• Subjects with a sitting blood pressure of 140/90 mmHg or above at screening.
• Subjects with evidence or history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China
Pfizer Investigational Site
Beijing, China

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

ClinicalTrials.gov Identifier:	NCT00452894 History of Changes
Other Study ID Numbers:	A3051076
First Posted:	March 28, 2007
Last Update Posted:	April 1, 2008
Last Verified:	March 2008

Additional relevant MeSH terms:

Varenicline; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents	Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs