To assess safety, tolerability and PK of AZD9977 in Japanese subjects
Research type
Research Study
Full title
A Phase I, randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 Following Single and Multiple-ascending Dose Administration in Japanese Healthy Volunteers
IRAS ID
255496
Contact name
Pablo ForteSoto
Contact email
Eudract number
2018-003984-68
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
This is a randomised, single-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics (PK) of AZD9977 oral suspension in healthy male Japanese volunteers. AZD9977 is being developed by AstraZeneca, for treatment of patients with heart failure with preserved ejection fraction (HFpEF). This condition is often associated with other illnesses such as overweight/obesity, diabetes mellitus, chronic obstructive airways disease and salt-sensitive high blood pressure. In heart failure, the sick heart and the associated risk factors are treated. For HFpEF researchers believe that it is particularly important to control the high blood pressure. AZD9977 is an oral, selective mineralocorticoid receptor (MR) modulator. Studies in laboratory animals showed that AZD9977 at clinically relevant doses is effective in reducing damage to the heart and kidneys along with a lower risk of treatment-related increases in potassium salts in the blood when compared with currently available MR drugs.
The main purpose of the study is to see how safe the study drug is and how well it is tolerated. In addition, the study will investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as PK). Blood and urine samples will also be collected for future exploratory tests (including biomarkers and genetic research), investigation into drug breakdown products (metabolites) and effects on blood salt concentrations.
The study consists of a screening period, a treatment period of in-house stay at the clinical unit and a final follow-up visit. Three cohorts of different dose levels are planned, with the option to add two further cohorts if needed. Single doses of oral suspension will be administered on Days 1 and 9, with twice daily doses on Days 3 to 8 of each treatment period.
This is not a first-in-human clinical trial. Four Phase I studies in the AZD9977 development program were completed. Researchers are convinced that the potential benefits of evaluating AZD9977 as a potential treatment for HFpEF outweigh the potential risks for subjects participating in this trial.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0586
Date of REC Opinion
22 Nov 2018
REC opinion
Favourable Opinion