Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Balcinrenone · 1 trial · 1 indication
To compare the PK of a single oral dose of balcinrenone in participants with mild and moderate hepatic impairment to those with normal hepatic function
To compare the PK of a single oral dose of balcinrenone in participants with mild and moderate hepatic impairment to those with normal hepatic function
To compare the PK of a single oral dose of balcinrenone in participants with mild and moderate hepatic impairment to those with normal hepatic function
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Subjects with Mild Impairment will receive a single oral dose of balcinrenone under fasted conditions. |
| Group 2 | EXPERIMENTAL | Subjects with Moderate Impairment will receive a single oral dose of balcinrenone under fasted conditions. |
| Group 3 | EXPERIMENTAL | Healthy participants will receive a single oral dose of balcinrenone under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Balcinrenone | DRUG | 50 mg, Immediate release capsule to be taken orally. |
Inclusion Criteria: \- Participant must be 18 to 79 years of age, inclusive, at the time of signing the informed consent. For participant with hepatic impairment: * Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment Child Pugh Class A or B (eg, no clinically s...
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.