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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03468725 | Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101 | PHASE1 | COMPLETED | 20 | — | — | Feb 13, 2018 | Jul 31, 2018 | Sep 18, 2018 | 1 | United Kingdom |
To assess AEs as a criteria of safety and tolerability
To assess ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability
To assess vital signs as a criteria of safety and tolerability
To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG
To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response
| Arm | Type | Description |
|---|---|---|
| XPF-008 | EXPERIMENTAL | Single oral dose |
| Placebo | ACTIVE_COMPARATOR | Single oral dose |
| Name | Type | Description |
|---|---|---|
| XPF-008 | DRUG | Capsule filled with XEN1101 |
| Microcrystalline Cellulose | DRUG | Placebo capsule |
Key Inclusion Criteria: * Healthy male aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 30.0 kg/m2 * Right-handed only * Must agree to use effective methods of contraception, if applicable * Able to swallow multiple capsules * Able to provide written, personally ...