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Verinurad ER8 formulation · 1 trial · 1 indication
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
| Arm | Type | Description |
|---|---|---|
| Treatment 1 | EXPERIMENTAL | During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state. |
| Treatment 2 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state. |
| Treatment 3 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state. |
| Treatment 4 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. |
| Treatment 5 | EXPERIMENTAL | During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. |
| Name | Type | Description |
|---|---|---|
| Verinurad ER8 capsule formulation (fasted) | DRUG | Each participant will receive single-dose treatment of 12 mg verinurad ER8 capsule with 240 mL water, following an overnight fast of at least 10 hours. |
| Verinurad A-capsule formulation (fasted) | DRUG | Each participant will receive single-dose treatment of 12 mg verinurad A-capsule with 240 mL water, following an overnight fast of at least 10 hours. |
| Verinurad A-capsule formulation (fed) | DRUG | Each participant will receive single dose treatment of 12 mg verinurad A-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast). |
| Verinurad B-capsule formulation (fasted) | DRUG | Each participant will receive single-dose treatment of 12 mg verinurad B-capsule with 240 mL water, following an overnight fast of at least 10 hours. |
| Verinurad B-capsule formulation (fed) | DRUG | Each participant will receive single dose treatment of 12 mg verinurad B-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast). |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and female participants aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. 3. Have a body mass index (BMI) between 18 and 30 kg/m2 an...
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Verinurad ER8 formulation is an investigational small molecule being developed for chronic kidney disease. It is currently in Phase 1 clinical development. The drug is being studied to assess its relative bioavailability under fasted and fed conditions in patients with chronic kidney disease.
Verinurad ER8 formulation is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate this investigational drug for the treatment of chronic kidney disease.
Verinurad ER8 formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, which assessed the relative bioavailability of different formulations under fasted and fed conditions.
Verinurad ER8 formulation has one completed clinical trial registered under NCT04024501, titled 'A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition.' This Phase 1 study enrolled 25 participants with chronic kidney disease in Germany and included healthy volunteers.
Verinurad ER8 formulation is a specific extended-release formulation of the drug verinurad. The 'ER8' designation indicates the extended-release version being studied for chronic kidney disease. This formulation is being evaluated for its bioavailability compared to other formulations in clinical trials.