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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05780645 | A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants | PHASE1 | COMPLETED | 80 | — | — | Mar 15, 2023 | Feb 26, 2024 | Jun 6, 2024 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Regimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions. Optional Regimens C, D, E, and F |
| Cohort 2 | EXPERIMENTAL | Regimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions. Optional Regimens: I, J, K, and L |
| Name | Type | Description |
|---|---|---|
| ALXN2050 MR Prototype Tablet | DRUG | Participants will receive various doses of the MR Prototype Tablet orally. |
| ALXN2050 Immediate Release (IR) Tablet | DRUG | Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally. |
| ALXN2050 MR Prototype Mini-Tablet | DRUG | Participants will receive various doses of the MR Prototype Mini-Tablet orally. |
Inclusion Criteria: * Healthy males or non-pregnant, non-lactating healthy females. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematolog...