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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00858325

Enrollment

Registered

2009-03-09

Start date

2009-02-28

Completion date

2009-03-31

Last updated

2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Cubicin, PK, China Registration, Pharmacokinetics

Brief summary

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.

Interventions

DRUGDaptomycin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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.	On therapy evaluation on Day1~9.

Secondary

Measure	Time frame
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).	On therapy evaluation on Day1~9.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026