Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Daptomycin

Criteria

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)