A metabolite identification study in SPR720 PK samples
Research type
Research Study
Full title
An exploratory study to identify major metabolites in both plasma and urine samples following multiple oral doses of SPR720 in subjects who received either 500 mg or 1000 mg of SPR720 daily in Study SPR720-101.
IRAS ID
287042
Contact name
Annelize Koch
Contact email
Sponsor organisation
Spero Therapeutics Inc.
Duration of Study in the UK
0 years, 2 months, 17 days
Research summary
This study is an exploratory analysis study to identify metabolites in samples obtained for the measurement of SPR720 in the blood (plasma) and urine.
Metabolites are by-products produced when a drug is broken down to produce its’ effect. Some metabolites are required to allow the drug to produce its’ desired effect on the body (active metabolites), other metabolites are inactive with no effect and some metabolites may have a toxic effect on the body if they are not removed.
The purpose of this analysis is to provide more information and a better understanding to the study sponsor as to what metabolites are produced when SPR720 is broken down in the body, what levels of different metabolites are identified and to gather more information as to how these metabolites impact the overall effect of SPR720 in the body at different dose strengths.
The blood (plasma) and urine samples to be used for this analysis were obtained from participants who took part in a previous clinical trial of SPR720 (Reference 18.WA.0348) which was a first-in-human study to investigate how SPR720 works in the body, including assessing the safety of SPR720 along with a measure of how the body responds to the drug through taking blood and urine samples at set time points to measure the levels of SPR720 in the blood and urine and how this changed over a period of time.
In order to conduct this analysis, the study sponsor will utilise the blood and urine samples taken from participants who participated in Part 2 of the previous study (specifically Groups 1, 2, 4 & 5, a total of 24 participants).
Consent will be taken to permit the transport and subsequent analysis of samples from Simbec-Orion to WuXi AppTec / XenoBiotic Laboratories based in New Jersey, USA in order for this additional analysis study to be completed.
REC name
Wales REC 1
REC reference
20/WA/0239
Date of REC Opinion
21 Sep 2020
REC opinion
Further Information Favourable Opinion