Safety, Tolerability, PK&PD of AZD4721 SAD+Bioavailability
Research type
Research Study
Full title
A Phase I Single-blind, Randomised, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AZD4721 Solution After Single Ascending Doses, and to Compare the Oral Bioavailability of Single Doses of Solution and Suspension in Healthy Subjects
IRAS ID
131742
Contact name
James Ritter
Contact email
Eudract number
2013-001469-17
ISRCTN Number
N/a
Research summary
AZD4721 blocks a target on the surface of inflammatory cells and has potential as a new oral treatment for inflammatory diseases, including chronic obstructive pulmonary disease (COPD). This first-in-human study will assess the safety and tolerability of AZD4721 in healthy volunteers, and will characterise how the body handles (ie absorbs, distributes and eliminates) this drug together with its effects on certain inflammatory cells. This first part of the study will be a placebo (dummy treatment) controlled investigation of single doses of AZD4721 solution in sequential groups of healthy men and in women of non-childbearing potential. Whether a subject receives placebo or active drug will be determined randomly (like tossing a coin), and the subjects will not be told which treatment they have received (“single-blind”). Each group of subjects will receive the same dose of active, and provided the drug is safe and well tolerated the next group will be dosed with a larger dose than the last one up to a limit determined by the preclinical safety studies. In a second part of the study two formulations of AZD4721 (a solution and a suspension) will be compared to estimate whether these cause differences in drug absorption.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0304
Date of REC Opinion
15 Jul 2013
REC opinion
Further Information Favourable Opinion