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

NCT ID: NCT01156077

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-02
• Study Completion Date: 2011-09-24

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

oral TR-701 FA

Single oral dose of 200 mg TR-701

Group Type: EXPERIMENTAL

TR-701 FA

Intervention Type: DRUG

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

IV TR-701 FA

Single IV infusion of 200 mg TR-701 FA

Group Type: EXPERIMENTAL

TR-701 FA

Intervention Type: DRUG

TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline

Interventions

TR-701 FA

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

Intervention Type: DRUG

TR-701 FA

TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: BACKGROUND

PMID: 26910588 (View on PubMed)

Other Identifiers

TR701-111

Identifier Type: OTHER

Identifier Source: secondary_id

1986-026

Identifier Type: -

Identifier Source: org_study_id