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balcinrenone/ dapagliflozin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment ABC | EXPERIMENTAL | Participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively). |
| Treatment ACB | EXPERIMENTAL | The participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food. |
| Treatment BCA | EXPERIMENTAL | The participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule. |
| Treatment BAC | EXPERIMENTAL | The participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food on Day 1 and then followed by washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7 participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively). |
| Treatment CAB | EXPERIMENTAL | The participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule and then followed by washout period of 72 hours. On Day 7, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food. |
| Treatment CBA | EXPERIMENTAL | The participants will receive Treatment C (quinidine, fasted), balcinrenone/dapagliflozin capsule dosed together with a P-gp inhibitor tablets (2 doses of quinidine separated by 4 hours, 1 hour prior and 3 hours post balcinrenone/dapagliflozin administration, respectively), followed by a washout period of 72 hours. On Day 4, participants will receive Treatment B (fed), balcinrenone/dapagliflozin capsule dosed together with food, followed by a washout period of 72 hours. On Day 7, participants will receive Treatment A (reference, fasted), balcinrenone/dapagliflozin capsule. |
| Name | Type | Description |
|---|---|---|
| balcinrenone/ dapagliflozin | DRUG | Participants will be receiving balcinrenone/ dapagliflozine in fasted or fed condition. |
| quinidine | DRUG | Participants will be receiving quinidine orally in fasted condition. |
Main Inclusion Criteria: * Have a Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. * All females of childbearing potential must have a negative pregnancy test. * Females of childbearing potential must not be lactating and if heteros...
Balcinrenone is an investigational small molecule being developed by AstraZeneca PLC (AZN) as a combination product with dapagliflozin. It is being studied in healthy volunteers and in patients with chronic kidney disease, kidney failure, and hepatic impairment. The drug is in clinical development, including Phase 1 and Phase 3 trials.
Balcinrenone, in combination with dapagliflozin, is being studied for use in chronic kidney disease, specifically in patients with CKD stage 3b and 4. It is also being investigated in healthy participants and in patients with kidney failure or hepatic impairment to assess its safety and pharmacokinetics.
Balcinrenone is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials of the balcinrenone/dapagliflozin combination across multiple countries, including China, the United Kingdom, and the United States.
Balcinrenone is in clinical development, with trials in Phase 1 and Phase 3. The Phase 3 trial, BalanceD-CKD, is not yet recruiting and will evaluate the drug in patients with chronic kidney disease. Phase 1 trials have been completed in healthy participants to study pharmacokinetics.
Balcinrenone is being studied in several trials. NCT06651021 is a completed Phase 1 PK study in healthy Chinese participants. NCT06979388 is a completed Phase 1 food effect and drug interaction study. NCT07624305 is a Phase 3 trial in chronic kidney disease, and NCT07754331 is a Phase 1 study in kidney failure patients on haemodialysis.
Balcinrenone is the same as balcinrenone/dapagliflozin, which is the combination product being developed. The drug is studied as a fixed combination with dapagliflozin in clinical trials, and the name balcinrenone/dapagliflozin is used to refer to this investigational therapy.