Safety, tolerability, PK & PD of AZD9567 as MAD in volunteers
Research type
Research Study
Full title
A PHASE I, RANDOMISED, SINGLE-BLIND STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF MULTIPLE ASCENDING DOSES OF AZD9567 IN VOLUNTEERS WITH BMI BETWEEN 28 AND 38 kg/m2 AND A POSITIVE GLUCOSE TOLERANCE TEST (7.8-11.0 mmol/L) USING PREDNISOLONE AS POSITIVE CONTROL
IRAS ID
200686
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-005815-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 5 days
Research summary
Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. This is done by carrying out research studies (or clinical studies) such as this one.\n\nThe new medicine tested in this study is a compound called AZD9567 (referred to as the “study drug” throughout the remainder of this document). The Sponsor is developing the study drug for treating rheumatoid arthritis. Rheumatoid arthritis is an autoimmune disease (disease that causes the body to mistakenly attack its own tissues) that causes chronic inflammation of the joints.\n\nThe purposes of this study are to:\n•Determine how safe the study drug is and how well it is tolerated after multiple doses.\n•How the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted (removed from the body). This is called pharmacokinetics (PK) of a drug.\n•Investigate the effect of the study drug on the body by assessing the pharmacodynamics (PD) of the study drug.\n•To assess biomarkers for anti-inflammatory effects of the study drug, as well as for future research of the effects on glucose, cholesterol and bone metabolism. A biomarker is a biological molecule, which may be used as a marker for a substance or a disease of interest.\n•To further analyse the breakdown products of the study drug (metabolites) in urine and blood samples and evaluate the PK of Prednisolone (used to treat inflammatory conditions).\n\nThis study will recruit participants with impaired glucose tolerance (insulin resistant), males and females (of non-childbearing potential) between the ages of 18-60 years. A total of up to 54 participants will take part in the study.\n\nVital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for PK and PD analysis will be collected.\n
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0314
Date of REC Opinion
24 Mar 2016
REC opinion
Further Information Favourable Opinion