A MAD study to determine the safety, tolerability and PK of AZD9977
Research type
Research Study
Full title
A Phase 1, Randomized, Placebo controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 Following Multiple Ascending Dose Administration in Healthy Volunteers.
IRAS ID
239161
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Astra Zeneca AB
Eudract number
2017-004619-38
Duration of Study in the UK
0 years, 3 months, 5 days
Research summary
This is a single-site, randomised, single-blinded, placebo-controlled clinical trial to assess the safety, tolerability and pharmacokinetics (PK) following repeated ascending doses of orally administered AZD9977 in healthy male subjects. The study will include a screening visit, treatment period of 8 days and a final follow-up visit. During the treatment period eligible subjects will be resident at the clinical unit for 11 days/10 nights.
This is not the first time AZD9977 is administered in humans. A total of 77 subjects received single doses of AZD9977 in two Phase 1 clinical trials recently completed with the study drug. AZD9977 was well tolerated in all study subjects and no safety concerns have been identified. AZD9977 is being developed for the treatment of congestive heart failure (CHF), particularly in patients who still have relatively good heart pump function but suffer heart failure due to inflammation of the heart’s blood vessels. AZD9977 is thought to decrease scaring and inflammation in the heart and tissues surrounding the heart’s blood vessels, thereby having positive effects on both heart and blood vessel functions.
The main purpose of the study is to see how safe the study drug is and how well the body tolerates the study drug after repeated doses, administered orally to healthy adult subjects. The study will also 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) when the study drug is given repeatedly in healthy subjects (referred to as PK).
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0002
Date of REC Opinion
9 Feb 2018
REC opinion
Further Information Favourable Opinion