Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858325
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : January 22, 2010
Information provided by:

March 6, 2009
March 9, 2009
January 22, 2010
February 2009
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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. ]
Same as current
Complete list of historical versions of study NCT00858325 on Archive Site
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. ]
Same as current
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Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China
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.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Daptomycin
4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.
Other Name: Cubicin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2009
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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)
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Mathew Lo, Regional Product Director-Cubicin, AstraZeneca Pharmaceuticals
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Study Chair: Gang Chen, MD AZ Pharmaceuticals - China
Principal Investigator: Haiyan Li, MD Peking University Third Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP