A Phase 1 Mass Balance Study in 14C-OPC-61815
Research type
Research Study
Full title
A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects
IRAS ID
268711
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Otsuka Pharmaceutical Co., Ltd
Eudract number
2019-001968-29
Clinicaltrials.gov Identifier
19/NE/0214,
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
OPC-61815 belongs to a class of drugs called aquaretics, these drugs help remove water from the body without removing electrolytes, this is useful for the treatment of diseases which cause people to have low sodium in their blood which can cause a number of medical problems, it also is useful for people who have conditions causing fluid overload leading to oedema. OPC-61815 is being developed for use by injecting it into the veins (intravenous) for patients who have difficulty swallowing or have poor absorption from oral medications.
The purpose of this study is to determine the absorption, metabolism and excretion of OPC-61815, and to determine the metabolised products of OPC-61815 in the plasma, urine and faeces in healthy male Japanese subjects following a single intravenous dose.
Eight healthy Japanese subjects will be dosed with the intravenous radioactively labelled form of OPC-61815, subjects are expected to be resident in the unit for a minimum of 9 days and a maximum of 12 days.
Subjects will be confined to the trial site until at least Day 9. Subjects will be discharged from the trial site on Day 9 if the following discharge criteria are met:
• ≥ 90% mass balance recovery, and/or
• < 1% of the total radioactive dose is recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods.
If these criteria are not met by Day 9, subjects will remain at the trial site until any one of the discharge criterion are met up to a maximum of Day 10 to continue 24-hour blood, urine, and faeces collections for total radioactivity, unless otherwise agreed upon by the sponsor and investigator.REC name
North East - York Research Ethics Committee
REC reference
19/NE/0214
Date of REC Opinion
27 Aug 2019
REC opinion
Further Information Favourable Opinion