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

Bacterial Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156077
• Other study ID #: 1986-026
• Secondary ID: TR701-111
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2010
• Est. completion date: September 24, 2011

Study information

• Verified date: December 2018
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 24, 2011
• Est. primary completion date: September 24, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections

Intervention

Drug:
• TR-701 FA
Oral TR-701 FA 200 mg will be given as a single oral dose
• TR-701 FA
TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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