Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China
This study has been completed.
Information provided by:
First received: March 6, 2009
Last updated: January 21, 2010
Last verified: January 2010
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.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Study Start Date:
| Study Completion Date:
4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.
Other Name: Cubicin
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00858325
|Beijing, China |
||Gang Chen, MD
||AZ Pharmaceuticals - China
||Haiyan Li, MD
||Peking University Third Hospital
No publications provided
||Mathew Lo, Regional Product Director-Cubicin, AstraZeneca Pharmaceuticals
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 6, 2009
||January 21, 2010
||China: Food and Drug Administration
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014