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
  Purpose

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 Intervention Phase
Healthy
Drug: Daptomycin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 ]

Enrollment: 24
Study Start Date: February 2009
Study Completion Date: March 2009
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
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858325

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

No publications provided

Responsible Party: Mathew Lo, Regional Product Director-Cubicin, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00858325     History of Changes
Other Study ID Numbers: D1790C00002
Study First Received: March 6, 2009
Last Updated: January 21, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Cubicin
PK
China Registration
Pharmacokinetics

Additional relevant MeSH terms:
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014