- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00858325
Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China
January 21, 2010 updated by: AstraZeneca
A Two Cohort, Open Label, Single and Multiple Dose Pharmacokinetic Study of 4mg/Kg and 6mg/Kg Doses of Daptomycin in Healthy Chinese Subjects Living in China
The primary objective of this study is to characterise the pharmacokinetics and dose proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses of daptomycin in healthy Chinese volunteers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women (not of childbearing potential) of Chinese ethnicity
- Weight between 55Kg to 90Kg and have a Body Mass Index (BMI) between 18 and 25 kg/m2
- Have a calculated creatinine clearance within range from 80 to 120 ml/min inclusive
Exclusion Criteria:
- Unable to discontinue use of HMG-CoA reductase inhibitor therapy within 7 days prior to first dose of study drug through discharge from unit
- CPK > 2X ULN (upper limit of normal)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetic data will be obtained from the analysis of blood and urine samples that will be obtained at specific time points throughout the study. The pharmacokinetic samples will be collected on days 1, 4 through 8 and 9.
Time Frame: On therapy evaluation on Day1~9.
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On therapy evaluation on Day1~9.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Safety parameters (Incidence of AEs and SAEs, Deaths, Premature discontinuation due to an AE, regardless of relationship to study medication; Clinical lab data; Vital signs; ECG; Physical exam findings; Concomitant medications and adjunctive procedures).
Time Frame: On therapy evaluation on Day1~9.
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On therapy evaluation on Day1~9.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gang Chen, MD, AZ Pharmaceuticals - China
- Principal Investigator: Haiyan Li, MD, Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 6, 2009
First Submitted That Met QC Criteria
March 6, 2009
First Posted (Estimate)
March 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 22, 2010
Last Update Submitted That Met QC Criteria
January 21, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1790C00002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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