Pharmacokinetic Study of NER1006 in Healthy Subjects (QCL117983)
Research type
Research Study
Full title
A Pharmacokinetic Study of NER1006 in Healthy Subjects
IRAS ID
233058
Contact name
Philip Evans
Contact email
Sponsor organisation
Norgine Ltd.
Eudract number
2017-003440-20
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
The Sponsor is developing the study drug, NER1006 a powder for oral solution, to provide overall bowel cleansing.
The sponsor has submitted a license for approval in the EU and the US, and have a paediatric study planned for 2018 which will also meet the US post-approval requirements. The purpose of this study is to determine how key ingredients of NER1006 and its breakdown products are taken up and processed by the body (pharmacokinetic profile), and use these profiles to plan the blood sampling schedule for a PK study in young children, in order to avoid unnecessary blood sampling at inappropriate times.
The study will consist of one period involving up to 18 healthy male and female subjects, with at least 4 from each gender. The subjects will receive the NER1006 powder for oral solution formulation once, with the start of each dose separated by 2 hours.
Blood samples will be taken before the dose and at selected time points until 60 hours (2 and a half days) after the start of dosing for NER1006 dose 1. These blood samples will be used to test the amounts of the key ingredients of NER1006 and potential metabolites in the blood at different time points after the dose.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/1627
Date of REC Opinion
12 Oct 2017
REC opinion
Favourable Opinion