Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Collaborating Sponsors:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Pharmacokinetics of Fidaxomicin
Healthy Subjects
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Eligible subjects will check into the unit on Day-2 and remain confined to the clinical unit until Day 17. Cohorts 2 and 3, which may run in parallel, will only be enrolled after review of the availa...
Eligibility Criteria
Inclusion
- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continuing throughout the study period and for 90 days after final study drug administration
- Male subject must not donate sperm starting at Screening and throughout the study period and for at least 90 days after final study drug administration
- Inclusion Criteria for Japanese Subjects
- The subject is a healthy Japanese male who maintains the Japanese lifestyle, including diet and has a body mass index (BMI) of 18.0 to 28.0 kg/m2, inclusive.
- Inclusion Criteria for Caucasian Subjects
- The subject is a healthy Caucasian male and has a BMI of 18.0 to 32.0 kg/m2, inclusive
Exclusion
- The subject has any clinically significant disease history
- 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)
- The subject has any clinically significant abnormality
- The subject has a resting (i.e., seated for 5 minutes) pulse \<40 or \>90 beats per minute (bpm) at Screening or Day -2
- 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
- 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
- The subject has a history of chronic diarrhea or constipation
- 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)
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01813448
Start Date
February 1 2013
End Date
April 1 2013
Last Update
May 21 2014
Active Locations (1)
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1
Parexel
Glendale, California, United States, 91206