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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01156077
First received: June 11, 2010
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Bacterial Infection
Drug: TR-701 FA
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • Adolescent PK [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 20
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: IV TR-701 FA
Single IV infusion of 200 mg TR-701 FA
Drug: TR-701 FA
TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156077

Locations
United States, Arkansas
Trius Investigator Site 003
Little Rock, Arkansas, United States, 72202
United States, California
Trius Investigator 004
Los Angeles, California, United States, 90095
Trius Investigator Site 002
Orange, California, United States, 92868
Trius Investigator Site 001
San Diego, California, United States, 92123
United States, Ohio
Trius Investigator 005
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Director: Phillippe Prokocimer, M.D. Trius Therapeutics
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01156077     History of Changes
Other Study ID Numbers: TR701-111
Study First Received: June 11, 2010
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
antibiotic
Adolescents receiving antibiotics

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on August 18, 2014