PK FE study on balcinrenone/dapagliflozin fed and fasted when dosed with a P-gp inhibitor in HV
Research type
Research Study
Full title
A Phase I, randomised, single-dose, open-label, 3-period, 3-treatment, 3-way crossover study to assess the effect of food on balcinrenone/dapagliflozin pharmacokinetics in fed and fasted state and pharmacokinetics of balcinrenone when dosed with a P-gp inhibitor in healthy participants
IRAS ID
1011789
Contact name
Malin von Otter
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This trial is a single centre, open-label trial in up to 14 healthy, non-smoking, males and females between the ages of 18 and 55 years.
The clinical trial medication named balcinrenone/dapagliflozin has been administered several times to healthy volunteers. The purpose of this study is to assess the effect of food on balcinrenone/dapagliflozin pharmacokinetics in fed and fasted state and pharmacokinetics of balcinrenone when dosed with a P-gp inhibitor in healthy participant. AstraZeneca is developing the clinical trial medication for treating heart failure.
Balcinrenone is a new drug expected to help protect the heart and kidneys, but with an expected lower risk of causing high potassium levels in the blood compared to similar drugs on the market.
Dapagliflozin is an approved medication used for treating diabetes, heart failure, and chronic kidney disease. Dapagliflozin helps control blood sugar. It has benefits for the heart and kidneys in people with or without diabetes.
Quinidine is an approved medication used to treat certain heart disorders.
The trial will also investigate how the clinical trial medication is taken up, metabolised, distributed through the body and excreted and if this process is altered by food by giving the clinical trial medication in presence and absence of meals. The clinical trial will see if taking quinidine along with clinical trial medication changes how balcinrenone behaves in the body.
The trial consists of:
• Screening period of 28 days
• In-house treatment period - Admission on Day -1 and be required to stay in the Unit for 11 days and 10 nights.
3 Treatment Periods (A, B & C)
• Dosing will occur on Days 1, 4, and 7, and tests performed until 72 hours after each dosing.
• Safety follow up 5 - 7 days (Day 12-14) after the last study
Total time in clinical trial - approximately 6 weeks.REC name
Wales REC 1
REC reference
25/WA/0107
Date of REC Opinion
7 May 2025
REC opinion
Further Information Favourable Opinion