Comparing the PK of AZD9977 formulations in healthy male subjects
Research type
Research Study
Full title
An Open-Label, Randomized, Cross Over Single Oral Dose Study Comparing the Pharmacokinetics of Different Formulations of AZD9977 (Part A) and Influence of Food (Part B) in Healthy Males subjects
IRAS ID
187582
Contact name
Muna Albayaty
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-002807-26
Duration of Study in the UK
0 years, 2 months, 13 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.
The new medicine tested in this study is a compound called AZD9977 (referred to as the “study drug” throughout the remainder of this document). The Sponsor is developing the study drug for treating chronic kidney disease, including kidney diseases resulting from diabetes complications (diabetic nephropathy).
The main purposes of the study are:
• To compare three different extended-release formulations with different release rates (FAST, INTERMEDIATE and SLOW) to an immediate-release formulation and to determine the amount of drug that is actually absorbed from a given dose (bioavailability).
• Part B of this study will assess the influence of food when one of the extended‑release rate formulations evaluated in Part A is taken with a meal.
• To see how safe the study drug is and how well it is tolerated after dosing.This study will recruit healthy, non-smoking males between the ages of 18 and 50 years. A total of approximately 12 participants will take part in the study.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood for PK analysis will be collected.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/1416
Date of REC Opinion
15 Oct 2015
REC opinion
Further Information Favourable Opinion