SAD & MAD study to assess safety tolerability PK PD and FE of AZD7986
Research type
Research Study
Full title
A phase I, Randomised, Single-Blind Placebo-Controlled, 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple oral doses of AZD7986 in Healthy Volunteers
IRAS ID
163878
Contact name
Annelize Koch
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-004043-13
Duration of Study in the UK
0 years, 9 months, 12 days
Research summary
The new medicine tested in this study is a compound called AZD7986 (referred to as the “study drug” throughout the remainder of this document). The Sponsor (Astra Zeneca) is developing the study drug for treating chronic obstructive pulmonary disease. Chronic obstructive pulmonary disease (COPD) is a progressive disease that makes it hard to breathe. "Progressive" means the disease gets worse over time. This will be the first study in which the study drug will be given to humans, up until now it has only been tested in animals.
The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals. The study will also try to understand why different people respond differently to the same drug through DNA testing.
This study will recruit healthy, non-smoking, males and females (of non-childbearing potential) between the ages of 18 and 50 years (inclusive). Approximately 125 subjects will take part in the study. Additional subjects may be enrolled if needed. There will be approximately up to 45 subjects in this part of the study (Part 1). There will be approximately up to 80 subjects in this part of the study (Part 2).
Vital signs, safety ECG measurements, telemetry ECG, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood and Urine samples for pharmacokinetic analysis will be collected.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1649
Date of REC Opinion
14 Nov 2014
REC opinion
Further Information Favourable Opinion