Assess PK of AZD7986 alone & with VER, ITR or DIL in healthy subjects
Research type
Research Study
Full title
AN OPEN-LABEL, NON-RANDOMISED, FIXED SEQUENCE STUDY ASSESSING THE PHARMACOKINETICS OF AZD7986 WHEN ADMINISTERED ALONE AND WITH MULTIPLE DOSES OF VERAPAMIL AND ITRACONAZOLE OR DILTIAZEM IN HEALTHY SUBJECTS
IRAS ID
194082
Contact name
Annelize Koch
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-002840-15
Duration of Study in the UK
0 years, 2 months, 13 days
Research summary
This study will recruit healthy, non-smoking, males and females (of non-childbearing potential) between the ages of 18 and 55 years (inclusive). A total of up to 15 subjects will take part in the study.
The medicine tested in this study is a compound called AZD7986. The Sponsor is developing the study drug for treating Chronic Obstructive Pulmonary Disease (COPD). COPD is a disease of the airways that causes inflammation and narrowing of the airways making it difficult to breath.
In this study, subjects will receive the study drug 3 times, once alone, once with verapamil and once with itraconazole or diltiazem.
Verapamil, itraconazole and diltiazem are commonly prescribed drugs that are registered for use in humans.
The main purpose of the study is to:
• Investigate the effect that verapamil and itraconazole or diltiazem have on how the study drug is taken up, distributed through the body, metabolised (chemically broken down) and excreted (removed from the body). This is called the pharmacokinetics (PK) of a drug.
• Investigate how safe the study drug is and how well it is tolerated when it is given with verapamil and itraconazole or diltiazem.Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic analysis will be collected.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0688
Date of REC Opinion
23 Dec 2015
REC opinion
Further Information Favourable Opinion