Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00858325
First received: March 6, 2009
Last updated: January 21, 2010
Last verified: January 2010

March 6, 2009
January 21, 2010
February 2009
Not Provided
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00858325 on ClinicalTrials.gov 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. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Daptomycin
4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.
Other Name: Cubicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2009
Not Provided

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)
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00858325
D1790C00002
No
Mathew Lo, Regional Product Director-Cubicin, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Chair: Gang Chen, MD AZ Pharmaceuticals - China
Principal Investigator: Haiyan Li, MD Peking University Third Hospital
AstraZeneca
January 2010

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