Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00452894
First received: March 26, 2007
Last updated: March 28, 2008
Last verified: March 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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:
No publications provided

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

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014