ADME study for [14C]-AK0529 in Healthy Male Subjects (QCL117992)
Research type
Research Study
Full title
An open label, single-dose, single-period study designed to assess the mass balance recovery, metabolite profile and metabolite identification of [14C]-AK0529 in healthy male subjects
IRAS ID
234705
Contact name
Philip Evans
Contact email
Sponsor organisation
Ark Biosciences Pty Ltd.
Eudract number
2017-003522-33
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
The sponsor is developing a new test medicine, AK0529, for the potential treatment of severe respiratory illness (illnesses of the airways) caused by the Respiratory Syncytial Virus (RSV). RSV is a common virus that usually causes mild, cold-like symptoms however RSV can be a frequent cause of severe respiratory illness, especially in infants and children under the age of 5 years, patients with a compromised immune system and the elderly.
The study will try to identify the amount of radioactivity found in blood, urine and faecal samples after a single dose of radiolabelled AK0529. "Radiolabelled’ means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body. Subjects will also provide blood, urine and faecal samples for us to look at the breakdown products of AK0529 and to find out the structure of these products. The amount of AK0529 found in the blood and urine will also be assessed.
The study will involve up to 7 healthy male volunteers. The 7 volunteers will each receive a single dose of 300 mg of radiolabelled AK0529 ([14C]- AK0529). Blood, urine and faecal samples will then be collected for approximately 8 days.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0589
Date of REC Opinion
5 Dec 2017
REC opinion
Favourable Opinion