A study for measuring copper balance in healthy volunteers
Research type
Research Study
Full title
An exploratory study to optimise the procedures and methodology for measuring copper balance in healthy male and female subjects
IRAS ID
270518
Contact name
Ben Hutter
Contact email
Sponsor organisation
Richmond Pharmacology Ltd
Duration of Study in the UK
0 years, 1 months, 30 days
Research summary
This is an exploratory study being conducted to evaluate the clinical methodology for measuring copper balance. There is no investigational product being given to the volunteers. The methods used in this study may then later be used in clinical trials with Investigational Medicinal Products (IMPs) where the measurement of copper input and output is required.\n\nThis study involves giving subjects a set menu (for all meals) and collecting urine and faecal samples. We will then measure the dietary copper input content (in all food and drink given) and the copper output (in the urine and faeces collected). Other than phlebotomy for blood sample collection, all clinical procedures are non-invasive and there are no foreseeable significant specific risks to subjects.\n\nSix volunteers (three male and three female) will participate. The study will last approximately 30 days (20 days for screening and 10 days for the in-house stay).\n\nWe will assess safety parameters (including physical examination, vital signs, laboratory evaluations, electrocardiograms) at screening only. During the in-house stay, volunteers will be monitored for adverse events and appropriate safety actions taken where needed.\n
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1321
Date of REC Opinion
17 Sep 2019
REC opinion
Favourable Opinion