Status:
COMPLETED
Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Bacterial Infection
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
Brief Summary
This is an open-label, multi-center, two-part, parallel-design study to assess the PK, safety, and tolerability of TR-701 FA and its active metabolite, TR-700, following a single oral dose (Part A) or...
Eligibility Criteria
Inclusion
- males and females, between 12 and 17 years of age, inclusive;
- receiving prophylaxis for or have a confirmed or suspected infection with Gram positive bacteria and receiving concurrent antibiotic treatment with Gram positive antibacterial activity
- in stable condition
- females must be premenarchal, surgically sterile, abstinent, or practicing an effective method of birth control
- males will either be surgically sterile, abstinent, or practicing an effective method of birth control
Exclusion
- relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results
- any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study
- physician-diagnosed migraine headaches
- history of infection with hepatitis or other significant hepatic disease
- females who are pregnant or breast feeding
Key Trial Info
Start Date :
June 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01156077
Start Date
June 2 2010
End Date
September 24 2011
Last Update
December 7 2018
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