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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02963116 | A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet | PHASE1 | COMPLETED | 12 | — | — | Dec 20, 2016 | Mar 1, 2017 | Mar 9, 2017 | 1 | United Kingdom |
Assessment of AUC of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
Assessment of AUC(0-last) of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
Assessment of Cmax of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | 10 mg rosuvastatin tablet alone (fasting state) |
| Treatment B | EXPERIMENTAL | 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state) |
| Treatment C | EXPERIMENTAL | 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state) |
| Treatment D | EXPERIMENTAL | 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state) |
| Treatment E | EXPERIMENTAL | 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state) |
| Name | Type | Description |
|---|---|---|
| AZD5718 IR tablet | DRUG | - |
| AZD5718 oral suspension | DRUG | - |
| Rosuvastatin tablet | DRUG | - |
Inclusion Criteria: For inclusion in the study, subjects should fulfill the following criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects (of non childbearing potential) aged 18 to 50 years (inclusive) ...