Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
NCT00452894
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers | |||
| Official Title ICMJE | A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Smoking | |||
| Intervention ICMJE | Drug: varenicline tartrate | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 14 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | March 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 45 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00452894 | |||
| Other Study ID Numbers ICMJE | A3051076 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||