Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Daptomycin

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

Intervention Type DRUG

Other Intervention Names

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Cubicin

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes