Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XPF-008 · 2 trials · 2 indications
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
To assess AEs as a criteria of safety and tolerability
To assess ECG as a criteria of safety and tolerability
To assess vital signs as a criteria of safety and tolerability
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
To evaluate the safety and tolerability of XEN1101 (XPF-010)
To assess the Food Effect on PK (Cmax) and the relative bioavailability/comparability (Cmax) of XEN1101 following single oral doses of XPF-010 (fed), XPF-008 (fed) and XPF-010 (fasted)
To assess the Food Effect on PK (AUC0-240h) and the relative bioavailability/comparability (AUC0-240h) of XEN1101 following single oral doses of XPF-010 (fed), XPF-008 (fed) and XPF-010 (fasted)
To evaluate the safety and tolerability of XEN1101
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
To evaluate the safety and tolerability of XEN1101 (XPF-010)
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
To evaluate the safety and tolerability of XEN1101 (XPF-010)
| Arm | Type | Description |
|---|---|---|
| XPF-008 | EXPERIMENTAL | Single oral dose |
| Placebo | ACTIVE_COMPARATOR | Single oral dose |
| Drug: XEN1101 XPF-008 Formulation Oral | EXPERIMENTAL | XEN1101 XPF-008 Formulation Part 1 - Single ascending dose: Single oral dose for each cohort Part 2 - Multiple ascending dose: 7 days of single oral dose daily for each cohort |
| Placebo - Microcrystalline cellulose oral | PLACEBO_COMPARATOR | Part 1- Single Ascending Dose: Single oral dose for each cohort Part 2 - Multiple Ascending Dose: 7 days of single oral dose daily for each cohort |
| Drug: XEN1101 XPF-008 Formulation Oral Drug: XEN1101 XPF-010 Formulation Oral | EXPERIMENTAL | XEN1101 XPF-008 and XPF-010 Formulation Cross Over Part 3 will explore dose proportionality of XPF-010 and confirm dosing for subsequent cohorts, and the food effect and relative bioavailability of XPF-010 compared to XPF-008 |
| Drug: XEN1101 XPF-010 Formulation Oral | EXPERIMENTAL | XEN1101 XPF-010 Formulation Oral Part 4 will explore multiple dose PK |
| Drug: XEN1101 XPF-010 Formulation Oral Drug: Itraconazole 400mg Oral | EXPERIMENTAL | XEN1101 XPF-010 Formulation + Itraconazole Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole (400mg, single dose, oral solution, fasted) |
| Name | Type | Description |
|---|---|---|
| XPF-008 | DRUG | Capsule filled with XEN1101 |
| Microcrystalline Cellulose | DRUG | Placebo capsule |
| XPF-010 | DRUG | Capsule filled with XEN1101 |
| Itraconazole 400mg | DRUG | Oral |
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 ...
XPF-008 is an investigational small molecule developed by Xenon Pharmaceuticals Inc. (ticker: XENE). It has been studied in Phase 1 clinical trials involving healthy volunteers. The specific therapeutic indications for XPF-008 have not been disclosed.
XPF-008 is being developed by Xenon Pharmaceuticals Inc., which trades under the ticker symbol XENE. The company has sponsored Phase 1 clinical trials for this asset.
XPF-008 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program remains investigational.
XPF-008 has been evaluated in two completed Phase 1 trials: NCT03468725, which assessed safety, tolerability, pharmacokinetics, and effects on transcranial magnetic stimulation in 20 healthy male volunteers in the United Kingdom, and NCT03340220, which studied single and multiple ascending oral doses in 130 healthy volunteers, also in the United Kingdom.
Yes, XPF-008 is also known as XEN1101. Both names refer to the same investigational small molecule developed by Xenon Pharmaceuticals Inc. The completed Phase 1 trials for XPF-008 were conducted under the XEN1101 designation.