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

NCT01156077 | Completed Phase 1

• 2 other identifiers: 1986-026TR701-111
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterial Infection

Keywords

antibiotic; Adolescents receiving antibiotics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

oral TR-701 FA

EXPERIMENTAL

Single oral dose of 200 mg TR-701

Drug: TR-701 FA

IV TR-701 FA

EXPERIMENTAL

Single IV infusion of 200 mg TR-701 FA

Drug: TR-701 FA

Interventions

TR-701 FA DRUG

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

oral TR-701 FA

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Related Publications (1)

• Bradley JS, Flanagan SD, Arrieta AC, Jacobs R, Capparelli E, Prokocimer P. Pharmacokinetics, Safety and Tolerability of Single Oral or Intravenous Administration of 200 mg Tedizolid Phosphate in Adolescents. Pediatr Infect Dis J. 2016 Jun;35(6):628-33. doi: 10.1097/INF.0000000000001096.

  PMID: 26910588 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: July 2, 2010
• Study Start: June 2, 2010
• Primary Completion: September 24, 2011
• Study Completion: September 24, 2011
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share