Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

AstraZeneca24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DaptomycinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Research Site

Beijing, China

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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