Safety, tolerability and PK of Eravacycline (TP-434) (QBR114943)

• Research type

  Research Study

• Full title

  A Randomised, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Ascending Doses of Oral Eravacycline (TP-434) Administered Multiple Times Daily for Seven Days

• IRAS ID

  120866

• Contact name

  Stuart Mair

• Sponsor organisation

  Tetraphase Pharmaceuticals, Inc.

• Eudract number

  2012-005258-40

• ISRCTN Number

  To be applied for

• Research summary

  The study drug, Eravacycline is being developed by Tetraphase Pharmaceuticals, Inc. as a new tetracycline antibiotic for both intravenous (into a vein) and oral (given by mouth) use. The study drug is a -broad spectrum- antibiotic which means that it can be used to treat a wide variety of bacterial infections. There are many drug resistant bacteria that are now emerging which mean that they are resistant to antibiotics and they are unable to kill the bacteria and treat the infection. An example of a multi-drug resistant bacteria is Methicillin resistant Staphylococcus Aureus (MRSA). The study drug has been designed to be active against these multi-drug resistant bacteria. The purpose of the study is to compare how different dose levels of the study drug are taken up by the body (absorbed) and broken down (metabolised) when they are given as a capsule multiple times. There will be up to 7 groups of subjects in this study. In each group, 6 subjects will receive the study drug (Eravacycline) and 2 will receive a placebo. It is initially planned to enrol 4 groups (A-D). It is planned that Subjects in Group A will receive 150 mg or placebo, and subsequent groups will receive escalating doses depending upon safety, tolerability and PK profile of the proceeding group. Up to 3 additional groups may be enrolled depending on the results from groups A-D. These groups may receive a higher dose than was given in Groups A-D, a lower dose or more frequent doses of the study drug. The maximum daily dose given will not exceed 450 mg twice daily (i.e. 900mg per day).

• REC name

  Wales REC 1

• REC reference

  13/WA/0009

• Date of REC Opinion

  18 Jan 2013

• REC opinion

  Further Information Favourable Opinion