Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

This study has been completed.

First Received: March 26, 2007 Last Updated: March 28, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00452894

Purpose

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	Intervention	Phase
Smoking	Drug: varenicline tartrate	Phase I

MedlinePlus related topics: Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	14
Study Start Date:	March 2007
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452894

Locations

China
Pfizer Investigational Site
Beijing, China

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

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A3051076
Study First Received:	March 26, 2007
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00452894 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Smoking
Healthy
Varenicline

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on May 07, 2009