A FIH, SAD, MAD and FE study of AZD0284 in healthy subjects
Research type
Research Study
Full title
A PHASE I RANDOMIZED SINGLE-BLIND PLACEBO-CONTROLLED 2-PART STUDY TO ASSESS THE SAFETY, TOLERABILITY AND PHARMACOKINETICS AND PHARMACODYNAMICS OF AZD0284 FOLLOWING SINGLE AND MULTIPLE ASCENDING DOSE ADMINISTRATION TO HEALTHY SUBJECTS
IRAS ID
215260
Contact name
Muna Albayaty
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2016-003305-34
Duration of Study in the UK
0 years, 5 months, 13 days
Research summary
This is a first-in-human, randomised, single-blind, placebo-controlled, sequential group clinical trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeated doses of the Sponsor’s study medication, AZD0284, in healthy volunteer subjects.
The study will consist of two parts. Part 2 is interleaved with Part 1. Healthy subjects will be allocated to one of six cohorts in Part 1, or to one of three cohorts in Part 2, to allow the researchers to progressively increase the dose strength of the study drug (dose escalation) during the trial. A single dose of the study drug will be administered orally, under fasted conditions (Part 1A). To test the effect of food, subjects who participated in one of these cohorts will be selected to receive a second dose of the study drug orally, under fed conditions (Part 1B), at least 7 days after they received the first dose. In each cohort of Part 1, six subjects will be randomised to receive the active study drug (AZD0284) and two will receive dummy study drug (placebo). In Part 2, subjects will receive the study drug once or twice daily for between 7 to 14 days, dependent on the emerging results of Part 1. In each cohort of Part 2, six subjects will be randomised to receive AZD0284 and three will receive placebo. If the researchers find it necessary to increase the dose strength to levels higher than originally planned, up to two cohorts may be added to either study part. All parts of the study will include a screening visit, treatment period during which subject have to stay in-house at the Clinical Unit, and follow-up visits.
This will be the first time AZD0284 is administered in humans. It is being developed by AstraZeneca AB for the management of psoriasis. Research has shown that for some patients the existing medication looses its ability to work effectively; and, some patients have side effects or the existing medication does not work well for them. Therefore, it is important to investigate new possibilities for therapy.
The main purpose of the study is to see how safe the drug is and how well the body tolerates the study medication after single and repeated doses, administered orally to healthy research subjects, under fasted and fed conditions. The study will also investigate how the study medication is absorbed (taken up by the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) in healthy subjects, under fasted conditions, by measuring the amount of study medication and metabolites (breakdown products) in blood and urine samples. The study will also investigate the effect of food on absorption of the study medication and the effect of the study medication on liver enzymes that are involved in drug metabolism by measuring specific biomarkers in blood and urine samples. The study includes investigations into the way in which the study medication works (mechanism of action); how safe it is for the heart by measuring the QT interval (cardiac safety evaluation) and the role of genetics on the effects of the study medication (pharmacogenetic evaluation).
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0543
Date of REC Opinion
26 Oct 2016
REC opinion
Favourable Opinion