Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04724837 | Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial) | PHASE2 | COMPLETED | 542 | — | — | Apr 28, 2021 | Jun 1, 2023 | Jul 30, 2024 | 164 | United States, Argentina +17 |
| NCT04991571 | Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants | PHASE1 | COMPLETED | 27 | — | — | Jul 29, 2021 | Oct 22, 2021 | Nov 23, 2021 | 1 | United States |
The effect of zibotentan 1.5/dapagliflozin 10 mg versus dapagliflozin 10 mg on UACR was assessed.
Plasma sample will be collected to understand the PK profiling of zibotentan metabolites and to meet the regulatory requirements.
Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated.
Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated.
Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated.
Relative bioavailability of zibotentan and dapagliflozin after dosing with two different FDC formulations and dosing with separate formulations of zibotentan and dapagliflozin will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Zibotentan Dose A + Dapagliflozin | EXPERIMENTAL | Participants will receive once daily oral dose A of zibotentan and 10 mg dapagliflozin for 12 weeks. |
| Zibotentan Dose B + Dapagliflozin | EXPERIMENTAL | Participants will receive once daily oral dose B of zibotentan and 10 mg dapagliflozin for 12 weeks. |
| Placebo + Dapagliflozin | EXPERIMENTAL | Participants will receive once daily oral dose of dapagliflozin 10 mg and placebo for 12 weeks. |
| Part 1 | EXPERIMENTAL | Participants will be administered with zibotentan once daily for 5 days. |
| Part 2: Treatment Sequence ABC | EXPERIMENTAL | Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment A; Treatment B; Treatment C) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods. |
| Part 2: Treatment Sequence BCA | EXPERIMENTAL | Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment B; Treatment C; Treatment A) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods. |
| Part 2: Treatment Sequence CAB | EXPERIMENTAL | Each participant will receive 3 single-dose treatments of zibotentan and dapagliflozin (Treatment C; Treatment A; Treatment B) in 3 treatment periods, separated by a washout period of at least 7 days between treatment periods. |
| Name | Type | Description |
|---|---|---|
| Zibotentan | DRUG | Participants will receive zibotentan as per the arms they are randomized. |
| Dapagliflozin | DRUG | Participants will receive 10 mg dapagliflozin as per the arms they are randomized. |
| Placebo | DRUG | Participants will receive placebo as per the arms they are randomized to. |
| Zibotentan (Treatment A) | DRUG | Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2. |
| Dapagliflozin (Treatment A) | DRUG | Dapagliflozin tablet will be administered orally as single dose in Part 2. |
| Zibotentan/Dapagliflozin - Formulation 1 (Treatment B) | DRUG | Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. |
| Zibotentan/Dapagliflozin - Formulation 2 (Treatment C) | DRUG | Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Diagnosis of Chronic kidney disease (CKD), defined as: (a) eGFR chronic kidney disease epidemiology collaboration (CKD-EPI) ≥ 20 mL/min/1.73 m\^2, and (b) UACR ≥ 150 and ≤ 50...