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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bacterial Infection

Intervention / Treatment
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* Drug: TR-701 FA
* Drug: TR-701 FA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral TR-701 FA<br>Single oral dose of 200 mg TR-701 | Drug: TR-701 FA<br>* Oral TR-701 FA 200 mg will be given as a single oral dose<br>|
| Experimental: IV TR-701 FA<br>Single IV infusion of 200 mg TR-701 FA | Drug: TR-701 FA<br>* TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent PK | To describe the single-dose pharmacokinetics (PK) of IV and oral TR-701 FA administration in 12 to 17 year old adolescent patients, based on the individual plasma and urine concentration-time data. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic, Adolescents receiving antibiotics