Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Daptomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858325

D1790C00002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)