NCT01156077
Completed
Phase 1
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
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 sites20 target enrollmentJune 2, 2010
Overview
- Phase
- Phase 1
- Intervention
- TR-701 FA
- Conditions
- Bacterial Infection
- Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Enrollment
- 20
- Primary Endpoint
- Adolescent PK
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
oral TR-701 FA
Single oral dose of 200 mg TR-701
Intervention: TR-701 FA
IV TR-701 FA
Single IV infusion of 200 mg TR-701 FA
Intervention: TR-701 FA
Outcomes
Primary Outcomes
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.
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