NCT00452894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2007

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

First QC Date

March 26, 2007

Last Update Submit

March 28, 2008

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

varenicline tartrateDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Beijing, China

Location

Related Links

MeSH Terms

Conditions

Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 28, 2007

Study Start

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

CN(1)