Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 17
Updated:5/4/2016
Start Date:June 2010
End Date:September 2011

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A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Adolescent Patients

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 IV dose (Part B) of TR-701 FA in 12 to 17 year old adolescent
patients.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
5
sites
Orange, California 92868
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Orange, CA
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Columbus, Ohio 43205
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Columbus, OH
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Little Rock, Arkansas 72202
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Little Rock, AR
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Los Angeles, California 90095
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Los Angeles, CA
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San Diego, California 92123
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San Diego, CA
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