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

Phase 1

Completed

• Conditions: Bacterial Infection
• Interventions: Drug: TR-701 FA

• Registration Number: NCT01156077
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-02
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-02
• Primary Completion: 2011-09-24
• Study Completion: 2011-09-24
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral TR-701 FA	TR-701 FA	Single oral dose of 200 mg TR-701
IV TR-701 FA	TR-701 FA	Single IV infusion of 200 mg TR-701 FA

Primary Outcome Measures

Name	Time	Method
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.