Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00452894
• Collaborator: (none)
• Enrollment: 14
• Location: 1

Study Details

Study Description

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

• Study Type: Interventional
• 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: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Beijing		China

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00452894
• Other Study ID Numbers: A3051076
• First Posted: Mar 28, 2007
• Last Update Posted: Apr 1, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Varenicline

Study Results

No Results Posted as of Apr 1, 2008