An ADME Study of [14C]SJP-0008 in Healthy Male Volunteers (QSC204464)
Research type
Research Study
Full title
A Single Dose Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]SJP-0008 in Healthy Male Subjects After an Oral Dose
IRAS ID
297243
Contact name
Akira Ohtori
Contact email
Sponsor organisation
Senju Pharmaceutical Co, Ltd
Eudract number
2021-002615-65
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
The sponsor is developing the test medicine, SJP-0008, to treat Central Retinal Artery Occlusion (CRAO). This is a blockage to the vessels that carry blood to the eye and can lead to loss of eyesight.
This is a Phase 1, single centre, open-label study involving 6 healthy male subjects. This study will look at how the test medicine is taken up, broken down and removed from the body when given orally. Metabolites (break down products of the test medicine) will also be identified. The safety and tolerability will also be investigated.
The volunteers will be admitted to the clinic on Day -1 and following an overnight fast of at least 8 hours they will receive a single dose of the radiolabelled test medicine [14C]SJP-0008 as an oral suspension on one occasion. ‘Radiolabelled’ means that the test medicine has a radioactive component which enables researchers to track where the test medicine is in the body. The volunteers will attend the clinic for a minimum of 9 days (Day -1 to Day 8) and will receive the dose of the test medicine on Day 1. It is planned volunteers will be released as a group following study related procedures on Day 8. However, the volunteers stay may be extended up to a maximum of 48 hours (Day 10) if volunteers do not achieve the release criteria (the radioactivity is still high in volunteer samples).
If the criterion is still not met by Day 10, or if additional residency is not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator for individual volunteers.
The total time volunteers will be involved in this study is expected to be approximately 6 weeks from the screening visit until the end of the study.
REC name
Wales REC 2
REC reference
21/WA/0244
Date of REC Opinion
12 Aug 2021
REC opinion
Favourable Opinion