A Phase 1, Open-Label, Radiolabelled Study in Healthy Male Subjects
Research type
Research Study
Full title
KWA-0711 - A Phase I, Open-Label Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
IRAS ID
165677
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Kissei Pharmaceutical Co., Ltd
Eudract number
2014-004188-19
Duration of Study in the UK
0 years, 1 months, 15 days
Research summary
KWA-0711 is a medication under development to treat people who suffer with chronic constipation. It is anticipated to regulate water absorption in the gut, thereby softening stools and improving constipation.
This is an open label (i.e. volunteers and study staff will know the medication and dose being used for each volunteer), single oral dose study conducted in healthy male volunteers. KWA-0711 will be radiolabelled with 14C. Six volunteers will participate in the study as a single group.
The maximum expected duration of volunteer participation is approximately 8 weeks.
Each subject will reside at the Clinical Research Unit (CRU) from Day -1 (day before dosing) until at least Day 11 (240 hours post-dose).
Following an overnight fast volunteers will swallow a product containing 10 mg [14C] KWA-0711.
On Day 11, volunteers may be asked to remain resident within the CRU for a further period, or to attend additional non-residential visits on a daily basis, to allow for ongoing 24 hour excreta (urine and faeces) collections.
• If the criteria for discharge are not met, volunteers will be asked to remain resident and continue collections up to 336 hours post dose (Day 15).
• If after 336 hours post-dose, the criteria for discharge are not met, volunteers may be asked to collect 24 hour excreta samples on up to 2 further occasions on a non-residential basis. If needed, the 2 additional 24-hour non-residential collections will occur on Day 21 (± 1 day) and Day 28 (± 1 day).
Discharge Criteria,
• There are no medical reasons for a longer stay.
• No radioactivity is detected in 2 consecutive blood samples.
• Less than 1% of the total radioactive dose is recovered in excreta (urine + faeces) in 2 consecutive 24 hour collection periods.REC name
North East - York Research Ethics Committee
REC reference
15/NE/0069
Date of REC Opinion
18 Mar 2015
REC opinion
Favourable Opinion