NCT00858325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

First QC Date

March 6, 2009

Last Update Submit

January 21, 2010

Conditions

Healthy

Keywords

CubicinPKChina RegistrationPharmacokinetics

Outcome Measures

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.

    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).

    On therapy evaluation on Day1~9.

Interventions

DaptomycinDRUG

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

Also known as: Cubicin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Beijing, China

Location

MeSH Terms

Interventions

Daptomycin

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Gang Chen, MD

    AZ Pharmaceuticals - China

    STUDY CHAIR

  • Haiyan Li, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

February 1, 2009

Study Completion

March 1, 2009

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

CN(1)