Skip to main content
OpenTrials
Completed

NCT Number: NCT00858325

Pharmacokinetic Study 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

daptomycin

Drug

4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.

Other names: Cubicin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Mar 9, 2009
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.