PK of Eravacycline as Single and Multiple Doses (QBR115822)
Research type
Research Study
Full title
A Two Part Study to Investigate the Pharmacokinetic Profile of Different Oral Formulations of Eravacycline Administered as Single and Multiple Daily Doses
IRAS ID
135260
Contact name
Stuart Mair
Contact email
Sponsor organisation
Tetraphase Pharmaceuticals Inc.
Eudract number
2013-002460-42
ISRCTN Number
To be registered
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.
This study will be conducted in two parts. The purpose of Part 1 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 either as a capsule or a tablet with the aim of identifying a suitable formulation to be dosed in Part 2.
The purpose of Part 2 is to evaluate how this formulation is taken up by the body and broken down when dosed two or three times daily.In Part 1 of the study, it is planned to enrol 12 healthy volunteers. Each subject will receive 200mg of eravacycline on three separate occasions. On each occasion, the formulation of the eravacyline will be different. There will be 14 days between each dose of eravacycline.
In Part 2 of the study, 26 healthy volunteers will be recruited. Following review of the study data from Part 1 of the study and from another ongoing study, the dose regime for Part 2 will be selected. The dose will not exceed 900mg per day of eravacycline for 7 days. 20 subjects in Part 2 will receive the selected regimen of eravacycline, and 6 will receive a placebo (dummy drug). Blood and urine samples will be taken throughout the study to measure the amount of drug in the blood or urine, safety assessments will also be made throughout the study.
REC name
Wales REC 2
REC reference
13/WA/0231
Date of REC Opinion
19 Jul 2013
REC opinion
Favourable Opinion