Mass Balance, PK and metabolism study of [14C]-NT-814 (QSC203895)
Research type
Research Study
Full title
A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-NT-814 in Healthy Male Subjects After Oral Dosing
IRAS ID
285216
Contact name
Elizabeth Ballantyne
Contact email
Sponsor organisation
NeRRe Therapeutics Ltd.
Eudract number
2020-002987-30
Duration of Study in the UK
0 years, 0 months, 29 days
Research summary
Summary of Research
The Sponsor is developing the test medicine, NT-814, for the potential treatment of post menopausal vasomotor symptoms and other hormone dependent reproductive disorders in women and men.This is not the first time this medicine has been given to people. This is the first time however, that the test medicine will be given as a radiolabelled solution. This is where the test medicine has been labelled with radioactive 14C. This is used to locate the molecule within the body.
The study will try to assess how much radioactivity can be recovered from the blood, urine and faeces (mass balance recovery) after a single oral dose of [14C]-NT-814.
It will also look to identify the breakdown products (metabolites) of the drug. In addition, it will determine the rate and route of elimination of [14C]-NT-814, along with the level of test medicine in the blood. The safety and tolerability of the test medicine will be assessed.The study will consist of a single study period involving up to 6 healthy males. The subjects will receive a dose of 120 mg study drug, labelled with not more than 5.6MBq of 14C. Blood, urine and faecal samples will be collected from volunteers whilst they reside in the clinical unit for up to 336hours (Day 15).
If the required level of radioactivity has not been recovered by this point, the residency period may be extended up to Day 17. If the required level of radioactivity has not been recovered by Day 17, subjects will enter a home collection phase during which they will collect 24-hour urine and faeces on a daily basis up until Day 24 (or until the criteria are met) and then on a weekly basis starting on Day 31 (until criteria met or Day 45 reached).
Summary of Results
Given that this is a Phase I trial, no lay summary of results has been provided for reasons of commercial confidentiality.REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0998
Date of REC Opinion
14 Sep 2020
REC opinion
Favourable Opinion