A lead in study to investigate Gelatine's effect on healthy volunteers
Research type
Research Study
Full title
An open-label, 3-period, fixed-sequence study to determine the effect of gelatine intake on urinary oxalate and glycolate concentrations in healthy male and female subjects.
IRAS ID
234629
Contact name
Annelize Koch
Contact email
Sponsor organisation
Dicerna Pharmaceuticals
Duration of Study in the UK
0 years, 1 months, 19 days
Research summary
This study is considered a basic science study where we are testing the effect of gelatine on the levels of certain parameters in the blood and urine.
Gelatine is proposed to increase the levels of oxalate and glycolate within healthy volunteers and the objective of this study is to find out if that actually happens.
This study is being considered a lead in study prior to commencing a larger study involving a test drug that is being developed for the treatment of primary hyperoxaluria. In the first part of the larger study healthy volunteers will be given the test drug, however, healthy volunteers typically have low levels of oxalate and glycolate, meaning it might be difficult to observe the proposed effect of the drug (Lowering levels of oxalate and glycolate).
Should gelatine administered increase levels of oxalate and glycolate this approach will be integrated into the larger study, so the healthy volunteers have higher levels of such parameters meaning the effect of the test drug will be more obvious.
For this study 8 healthy male or female subjects will be recruited.
REC name
Wales REC 2
REC reference
17/WA/0276
Date of REC Opinion
16 Sep 2017
REC opinion
Favourable Opinion