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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03467100 | Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901 | PHASE1 | COMPLETED | 70 | — | — | Feb 19, 2018 | Dec 19, 2018 | Jul 22, 2019 | 1 | United Kingdom |
To assess AEs as a criteria of safety and tolerability
To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability
To assess vital signs as a criteria of safety and tolerability
| Arm | Type | Description |
|---|---|---|
| XEN901 | EXPERIMENTAL | Single ascending dose: Single oral dose for each cohort; Multiple ascending dose: 7 days of single oral dose twice daily for each cohort |
| Placebo | PLACEBO_COMPARATOR | Single Ascending Dose: Single oral dose for each cohort; Multiple Ascending Dose: 7 days of single oral dose twice daily for each cohort |
| Name | Type | Description |
|---|---|---|
| XEN901 | DRUG | Capsule filled with XEN901 |
| Inert Ingredients Oral Product | DRUG | Placebo capsule |
Key Inclusion Criteria: * Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 32.0 kg/m2 * Must agree to use effective methods of contraception, if applicable * Able to swallow capsules * Able to provide written, personally signed and dated I...