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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04024501 | A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition | PHASE1 | COMPLETED | 25 | — | — | Jul 20, 2019 | Sep 18, 2019 | Mar 18, 2021 | 1 | Germany |
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...