Mass Balance of Single Dose [14C]KLH-2109 in Healthy Subjects
Research type
Research Study
Full title
[14C]KLH-2109 A Phase I, Open-Label Study of Absorption,\nMetabolism, and Excretion Following a Single Oral Dose to Healthy\nSubjects
IRAS ID
232661
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Kissei Pharmaceutical Co., Ltd.
Eudract number
2017-001721-41
Duration of Study in the UK
0 years, 1 months, 23 days
Research summary
KLH 2109 is an investigational medicinal product aimed to help women suffering from endometriosis. Endometriosis is disease where the tissue of the womb grows outside of womb; which can cause intense pain and infertility.\nThe aim of this study is to determine the absorption, metabolism (drug breakdown in the body) and excretion of KLH 2109 in healthy female subjects following a single oral administration of 200 mg of KLH 2109 tagged with radioactive carbon 14.\nSubjects will be screened within 28 days prior to dosing on Day 1. Each subject will reside at the CRU for at least Day 11. Subjects may be discharged from the clinic any time after Day 11 if at least 90% of the administered radioactivity (based on the actual dose) has been recovered, or if 24 hour urine and faecal samples from 2 consecutive collections each have combined radioactivity less than 1.0% of the total administered radioactivity. Subjects may be asked to remain resident and continue excreta and blood collections up to Day 15 if the discharge criteria have not been met.\n\nIf after 336 hours post dose (Day 15), the criteria for discharge are still not met, subjects may be asked to collect 24 hour excreta samples on up to 2 further occasions on a non residential basis to allow extrapolation of urinary and faecal excretion. If needed, the 2 additional 24 hour non residential collections will occur on Day 21 (±1 day) and Day 28 (±1 day).\n\nThe effective radiation dose associated with this study, which is less than 1 mSv, is considered a minor risk for healthy subjects. The amount of radioactive material administered to the subjects is typical for this type of clinical trial and is necessary to be able to determine the levels of metabolites (drug breakdown products) in urine and faeces in order to achieve the objectives of the study.\n
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1359
Date of REC Opinion
24 Oct 2017
REC opinion
Further Information Favourable Opinion