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
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Daptomycin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin

Intervention Details:
  • Drug: Daptomycin
    4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.
    Other Name: Cubicin

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00858325

Research Site
Beijing, China
Sponsors and Collaborators
Study Chair: Gang Chen, MD AZ Pharmaceuticals - China
Principal Investigator: Haiyan Li, MD Peking University Third Hospital

Responsible Party: Mathew Lo, Regional Product Director-Cubicin, AstraZeneca Pharmaceuticals Identifier: NCT00858325     History of Changes
Other Study ID Numbers: D1790C00002
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010

Keywords provided by AstraZeneca:
China Registration

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents