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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05570539 | Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation | PHASE1 | COMPLETED | 30 | — | — | Oct 7, 2022 | Jul 1, 2024 | May 18, 2025 | 1 | United Kingdom |
To assess the comparison between Cmax following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
To assess the comparison between Cmin following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
To assess the comparison between AUC following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
| Arm | Type | Description |
|---|---|---|
| Immediate Release formulation | ACTIVE_COMPARATOR | IR Formulation |
| Extended Release formulation | EXPERIMENTAL | ER formulation |
| Name | Type | Description |
|---|---|---|
| BLU-5937 IR | DRUG | Each subject will receive two single and multiple administrations of Immediate Release reference formulation |
| BLU-5937 ER | DRUG | Each subject will receive single and multiple oral administrations of Extended Release formulation |
Inclusion Criteria: * Healthy males or non-pregnant, non-lactating healthy females Exclusion Criteria: * History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as...