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 |
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.
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
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