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

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

Status and phase

Completed

Phase 1

Conditions

Bacterial Infection

Treatments

Drug: TR-701 FA

Study type

Interventional

Funder types

Industry

Identifiers

NCT01156077

1986-026

TR701-111 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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