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 being studied in healthy volunteers, including healthy male volunteers, in early-stage clinical trials. It is being developed by Xenon Pharmaceuticals Inc. and is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities.
XPF-008 is being developed by Xenon Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XENE. The company is conducting Phase 1 clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational small molecule.
XPF-008 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers, and the drug remains in early-stage clinical testing.
XPF-008 has been studied in two completed Phase 1 clinical trials. The first, NCT03340220, evaluated safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses in 130 healthy volunteers in the United Kingdom. The second, NCT03468725, assessed safety, tolerability, pharmacokinetics, and effects on transcranial magnetic stimulation in 20 healthy male volunteers.
Yes, XPF-008 is also known as XEN1101. The clinical trials listed under XPF-008, including NCT03340220 and NCT03468725, use the name XEN1101 in their titles. Both names refer to the same investigational small molecule being developed by Xenon Pharmaceuticals Inc.