A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects

NCT01813448 Phase 1 COMPLETED

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.

Details

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2013-02
Completion	2013-04

Conditions

• Pharmacokinetics of Fidaxomicin
• Healthy Subjects

Interventions

• Fidaxomicin
• Placebo

Primary outcomes

• Pharmacokinetics (PK) of fidaxomicin in plasma (single dose): Lag time (tlag) — Days 1-5 (14 times)
• PK of fidaxomicin plasma (single dose): Time to attain maximum concentration (tmax) — Days 1-5 (14 times)
• PK of fidaxomicin in plasma (single dose): Maximum Concentration (Cmax) — Days 1-5 (14 times)
• PK of fidaxomicin in plasma (single dose): Area Under the Plasma Concentration - Time Curve (AUC) from Time Zero to Time of Last Measurable Concentration (AUClast) — Days 1-5 (14 times)
• PK of fidaxomicin in plasma (single dose): AUC - Time Curve from Time Zero to Infinity (aucinf) — Days 1-5 (14 times)
• PK of fidaxomicin in plasma (single dose): AUC - Time Curve from Time Zero to 12 hours (AUC 0-12h) — Days 1-5 (14 times)

Countries

United States