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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04550234 | A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol | PHASE1 | COMPLETED | 25 | — | — | Apr 13, 2021 | Jul 15, 2021 | May 10, 2023 | 1 | Germany |
The AUCinf of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters
The AUClast of verinurad, allopurinol and oxypurinol were assessed in fasted condition as PK parameters
The Cmax of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters
| Arm | Type | Description |
|---|---|---|
| Treatment 1 | EXPERIMENTAL | Subjects will receive verinurad prolonged release HPMC capsule and allopurinol tablet in fasted state on Day 1. |
| Treatment 2 | EXPERIMENTAL | Subjects will receive verinurad/allopurinol FDC capsule in fasted state on Day 1. |
| Treatment 3 | EXPERIMENTAL | Subjects will receive verinurad/allopurinol FDC capsule in fed state on Day 1. |
| Treatment 4 | EXPERIMENTAL | Subjects will receive verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1. |
| Treatment 5 | EXPERIMENTAL | Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1. |
| Name | Type | Description |
|---|---|---|
| Verinurad prolonged release HPMC capsule | DRUG | Randomized subjects will receive oral dose of verinurad HPMC capsule. |
| Allopurinol Tablet | DRUG | Randomized subjects will receive oral dose of allopurinol tablet. |
| Verinurad/Allopurinol FDC Capsule | DRUG | Randomized subjects will receive oral dose of Verinurad/Allopurinol FDC capsule. |
| Verinurad prolonged release gelatin Capsule | DRUG | Randomized subjects will receive oral dose of Verinurad gelatin capsule. |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture. * Have a body mass index between 18 and 30 kg/m\^2 (...