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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05708573 | Potential Drug Interaction Between ALXN2040 and Rosuvastatin | PHASE1 | COMPLETED | 20 | — | — | Feb 1, 2023 | Apr 5, 2023 | Apr 14, 2023 | 1 | United States |
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants will receive a single dose of rosuvastatin in the morning of Day 1 in Treatment Period 1. Following a washout period of 5 days, participants will receive ALXN2040 three times daily on Days 1 through 7 in treatment period 2. |
| Name | Type | Description |
|---|---|---|
| Rosuvastatin | DRUG | In Treatment Period 1, participants will receive a single oral tablet of rosuvastatin in the morning of Day 1. In treatment period 2, on the morning of Day 4, participants will receive a single 20 mg dose of rosuvastatin (co-administered with the morning dose of ALXN2040). |
| ALXN2040 | DRUG | In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7. |
Inclusion Criteria: * Medically healthy participants with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory safety evaluation (hematology, biochemistry, coagulation, and u...