A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects

Exclusion Criteria

• •1. The subject has any clinically significant disease history
• •2. The subject has a history of or current C.difficile infection or history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (history of appendectomy, hernia repair, and/or cholecystectomy is permitted)
• •3. The subject has any clinically significant abnormality
• •4. The subject has a resting (i.e., seated for 5 minutes) pulse \<40 or \>90 beats per minute (bpm) at Screening or Day -2
• •5. The subject has hypertension (defined as seated systolic blood pressure \[SBP\] \>140 mmHg or seated diastolic blood pressure \[DBP\] \>90 mmHg) or hypotension (defined as seated SBP \<90 mmHg or seated DBP \<50 mmHg) at Screening or Day -2
• •6. The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in on Day -2
• •7. The subject has a history of chronic diarrhea or constipation
• •8. The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or has a known positive history of human immunodeficiency virus (HIV)
• •9. The subject has a known or suspected allergy or hypersensitivity to any of the components of fidaxomicin, the macrolide antibacterial class of compounds, or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions