drugset / Trial / NCT00671814
Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults
RandomizedSingle-groupQuadruple-blindBasic science
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701
Timeline
- Start
- 2008-01-06
- Primary completion
- 2008-06-06
- Completion
- 2008-06-06
Publications
- Lodise TP, Bidell MR, Flanagan SD, Zasowski EJ, Minassian SL, Prokocimer P. Characterization of the haematological profile of 21 days of tedizolid in healthy subjects. J Antimicrob Chemother. 2016 Sep;71(9):2553-8. doi: 10.1093/jac/dkw206. Epub 2016 Jun 17.
- Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Linezolid | Other / unclassified | 600 mg | Oral |
| Subject | TR-701 | Small molecule | 200 mg | Oral |
| Subject | TR-701 | Small molecule | 300 mg | Oral |
| Subject | TR-701 | Small molecule | 400 mg | Oral |
| Subject | TR-701 | Small molecule | 600 mg | Oral |
| Subject | TR-701 | Small molecule | 800 mg | Oral |
| Subject | TR-701 | Small molecule | 1200 mg | Oral |
Indications
No indication recorded.