A Pharmacokinetic food effect study with AZD9977 in healthy males
Research type
Research Study
Full title
An Open-label, Randomized, Four-way Crossover Single Oral Dose Study Comparing the Pharmacokinetics of Four Different Formulations of AZD9977 (Part A) and Influence of Food and Lower Dose of a Selected Formulation (Part B) in Healthy Male Subjects
IRAS ID
256427
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2018-004319-37
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
This is an open-label, randomised, single oral dose study in healthy male subjects at a single study centre. In the first study part the pharmacokinetics (PK) of four different formulations of AZD9977 (Treatments A: capsule; B: HDL capsule; C: ODL capsule; D: tablet) are compared in a four-way crossover study design. This will be followed by a study part in which high (300 mg) and low (50 mg) doses of the selected formulation are investigated under fed conditions. There is a washout period of 2 days to 5 weeks between study parts. In addition, the study comprises a screening visit and a final follow-up visit. The planned doses of 300 mg and 50 mg AZD9977 are considered to yield clinically relevant blood drug levels. Similar doses have already been tested in previous studies in healthy volunteers. 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 evaluate the relative bioavailability of different formulations of AZD9977. Bioavailability refers to the fraction of an administered dose of unchanged study drug that reaches the systemic blood circulation. In addition, the food effect will be evaluated on two dose levels (300 mg and 50 mg) of the selected formulation. The study will also see how safe the study drug. The study results will guide the further pharmaceutical development and dosing regimen for future studies with AZD9977. No genetic research will be performed in this study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0633
Date of REC Opinion
24 Dec 2018
REC opinion
Favourable Opinion