Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00858325
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study Completion: 2009-03
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-06
• Study First Posted: 2009-03-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-21
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Beijing, China