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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01156077

Enrollment

Registered

2010-07-02

Start date

2010-06-02

Completion date

2011-09-24

Last updated

2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection

Keywords

antibiotic, Adolescents receiving antibiotics

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

Interventions

DRUGTR-701 FA

Oral TR-701 FA 200 mg will be given as a single oral dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Adolescent PK	2 days	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026