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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04727138 | 3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546 | PHASE1 | COMPLETED | 64 | — | — | Dec 8, 2020 | May 12, 2022 | May 16, 2022 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| EXS21546 Powder for Oral Suspension | EXPERIMENTAL | EXS21546 Powder for Oral Suspension |
| Placebo | PLACEBO_COMPARATOR | Placebo Powder for Oral Suspension |
| EXS21546 Granule in Capsule | EXPERIMENTAL | EXS21546 Granule in Capsule |
| Name | Type | Description |
|---|---|---|
| EXS21546 Powder for Oral Suspension | DRUG | EXS21546 Powder for Oral Suspension |
| EXS21546 Granule in Capsule | DRUG | EXS21546 Granule in Capsule |
| Midazolam | OTHER | Interaction |
| Food Effect | OTHER | Fed/Fasted |
| Placebo Powder for Oral Suspension | OTHER | Placebo Powder for Oral Suspension |
Inclusion Criteria: * BMI 18.0 to 30.0 kg/m2 * Weight ≥60 kg * Must adhere to contraception requirements Exclusion Criteria: * Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 * Subjects who have previously been administered IMP in this study. * Ev...