NAK-10 AME Study
Research type
Research Study
Full title
A Phase I, Absorption, Metabolism, and Excretion Study After a Single Oral and Intravenous Dose of 14C-Ibodutant in healthy Male and Female Subjects
IRAS ID
180503
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Menarini Ricerche S.p.A.
Eudract number
2015-000945-21
Duration of Study in the UK
0 years, 1 months, 6 days
Research summary
Ibodutant is an investigational medicinal product which is currently in clinical development for the treatment of irritable bowel syndrome (IBS). Irritable bowel syndrome is a functional bowel disorder in which abdominal pain or discomfort is associated with defecation or a change in bowel habits and with features of disordered defecation
The aim of this study is to determine the absorption, metabolism (breakdown in the body) and excretion of 14C ibodutant in healthy male and female subjects following a single oral and IV dose administration. Eight subjects will participate in the study and will be studied in a single group.
Subjects will be screened within 28 days prior to the first dose on Period 1, Day 1. For each period, if eligible for participation in the study, subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (the day before dosing). A single dose of 14C-ibodutant will be administered on Day 1 of Periods 1 and 2. Each subject will receive a single oral dose of 14C ibodutant in Period 1 and a single IV dose of 14C ibodutant in Period 2.For each period, subjects will reside at the CRU from Day –1 to at least Day 8 upon completion of the collection of urine and faeces samples.
For each period, subjects may be discharged as early as Day 8 if discharge criteria are met. Sample collection and confinement will continue until discharge criteria are met or the maximum stay of Day 11 is reached in each period.
Each subject will participate in 2 treatment periods. The dose administrations will be separated by a minimum of 21 days.
The activity administered to each subject in this study is 0.925 MBq (25 μCi) each for the oral and IV dose. This is considered to be an acceptable activity to give to healthy subjects and is considered adequate to define the disposition of 14C ibodutant. The effective radiation dose of less than 1 mSv to each subject is considered a minor risk.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0145
Date of REC Opinion
14 May 2015
REC opinion
Favourable Opinion