A study to assess the absolute bioavailability of AZD0284 (QCL117831)
Research type
Research Study
Full title
A Phase I Study to Assess the Absolute Bioavailability of a Single Oral Dose of AZD0284 and to Assess the Pharmacokinetics of a Single Intravenous Microdose of [14C]AZD0284 in Healthy Subjects
IRAS ID
217839
Contact name
Tariq Sethi
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2016-004260-19
Duration of Study in the UK
0 years, 1 months, 4 days
Research summary
The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. It occurs when skin cells are replaced more quickly than usual. The seriousness of psoriasis varies greatly from person to person. For some people it is a minor irritation, but for others it can have a major impact on their quality of life.
This is a single centre, open-label, non-randomised, single dose study in healthy subjects. It is planned to enrol 6 healthy male and female subjects. Subjects will receive a single oral dose of AZD0284 in the fasted state, followed by a radiolabelled IV infusion (injection directly into the vein) of AZD0284. 'Radiolabelled' means that the study drug has a radioactive component which helps researchers track where the drug is in the body.
The purpose of the study is to determine how much of AZD0284 is taken up by the body. The safety and tolerability of the drug will also be assessed. It is hoped that the study drug will improve the management of psoriasis.
REC name
HSC REC B
REC reference
17/NI/0008
Date of REC Opinion
30 Jan 2017
REC opinion
Further Information Favourable Opinion