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

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