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

December 6, 2018 updated by: Trius Therapeutics LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolescent PK
Time Frame: 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.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trius Therapeutics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 2, 2010

Primary Completion (ACTUAL)

September 24, 2011

Study Completion (ACTUAL)

September 24, 2011

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (ESTIMATE)

July 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 6, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1986-026
  • TR701-111 (OTHER: TrisuRX Unique ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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