Phase I study to assess the PD of AZD9977 in healthy male subjects
Research type
Research Study
Full title
A Phase I, Randomized, Single-Blind, Crossover Study to Assess the Pharmacodynamics of AZD9977 following Single-Dose administration to healthy male subjects
IRAS ID
183101
Contact name
Muna Albayaty
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2015-002224-11
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
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 (AstraZeneca) is developing the study drug for treating chronic kidney disease, including kidney diseases resulting from diabetes complications (diabetic nephropathy).
In this study subjects will receive the study drug, fludrocortisone (stabilises sodium and potassium levels to ensure the same electrolyte balance and to increase potassium elimination) eplerenone (used as a model, may influence the PD of the study drug) and study drug placebo.
The main purpose of the study is:
•To see if the study drug affects the kidney electrolyte (minerals in the body responsible for vital body processes) conduct. This is done by comparing the measured sodium/potassium ratio in urine after receiving a drug called eplerenone and after receiving a combination of study drug and eplerenone. The effect of study drug on the body is called Pharmacodynamics (PD)
•To compare the sodium/potassium ratio in urine after receiving study drug against receiving a placebo (“dummy treatment” that looks like the study drug but has no active ingredients).
•To see how safe the study drug is and how well it is tolerated after dosing
•To investigate how the study drug and eplerenone is taken up, metabolised (chemically broken down), distributed through the body and excreted; this is called pharmacokinetics (PK).
•To measure the urine produced as well as the amount of sodium and potassium excreted in urine after each urine collection.This study will recruit healthy, non-smoking males between the ages of 18 and 50 years. A total of approximately 24 subjects 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 and blood and urine samples for PD analysis will be collected.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/1030
Date of REC Opinion
8 Sep 2015
REC opinion
Further Information Favourable Opinion