A Phase 1 interventional study of XPF-008 and Microcrystalline Cellulose in Healthy Volunteers, sponsored by Xenon Pharmaceuticals Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Xenon Pharmaceuticals Inc. · Phase 1, Interventional, and Treatment
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The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK data, the clinical trial has been designed to include a pharmacodynamic read-out by incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or electromyographic (EMG) activity.
Part 3, 4 and 5: Phase 1, randomised, multi part study to evaluate the safety, tolerability, PK, relative bioavailability and food effect of single and multiple ascending doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment with Itraconazole.
Part 1 will study safety, tolerability, PK of single ascending doses (SAD) of XPF-008 as well as the impact and variability of single ascending doses of XPF-008 on TMS.
Part 2 will study the safety, tolerability and PK of multiple ascending doses (MAD) of XPF-008
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.
Part 4 will explore multiple dose PK.
Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole.
Xenon Pharmaceuticals Inc. is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: XPF-008
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: Microcrystalline Cellulose
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: XPF-010
XEN1101 XPF-010 Formulation Oral Part 4 will explore multiple dose PK
Drug: XPF-010
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)
Drug: Itraconazole 400mg
Capsule filled with XEN1101
Placebo capsule
Capsule filled with XEN1101
Oral
Parts 1 & 2: Number of Participants with Adverse Events (AEs)
To assess AEs as a criteria of safety and tolerability
Time frame: From screening (28 days prior to Day 1) through to 30 days post-final dose
Parts 1 & 2: Resting electrocardiogram (ECG)
To assess ECG as a criteria of safety and tolerability
Time frame: At screening (28 days prior to Day 1) through to 7 days post-final dose
Parts 1 & 2: Vital signs
To assess vital signs as a criteria of safety and tolerability
Time frame: At screening (28 days prior to Day 1) through to 7 days post-final dose
Part 3a: Maximum Observed Plasma Concentration (Cmax) of XEN1101
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3a: Area under the plasma concentration-time curve (AUC) of XEN1101
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3a: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3b: Maximum Observed Plasma Concentration (Cmax) of XEN1101
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)
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3b: Area under the plasma concentration-time curve (AUC) of XEN1101
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)
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3b: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
Part 4: Maximum Observed Plasma Concentration (Cmax) of XEN1101
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
Part 4: Area under the plasma concentration-time curve (AUC) of XEN1101
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
Part 4: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
Part 5: Maximum Observed Plasma Concentration (Cmax) of XEN1101
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
Time frame: Day 10 and Day 11
Part 5: Area under the plasma concentration-time curve (AUC) of XEN1101
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
Time frame: Day 10 and Day 11
Part 5: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
Parts 1 & 2: Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration in ng/mL
Time frame: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Time to the Maximum Observed Plasma Concentration (Tmax)
Tmax is the time in hours to reach Cmax following dosing
Time frame: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Terminal elimination half-life (t1/2)
The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase
Time frame: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)
The area under the plasma concentration-time curve \[in ng.h/mL\] from time zero to the time corresponding to the last quantifiable plasma concentration
Time frame: Day 1 predose through to 7 days post-final dose
Parts 3 to 5: Cardiac Safety
To evaluate the cardiovascular safety profile of XEN1101 (XPF-010), assessing potential ECG interval changes from baseline following dosing, in particular any effects on the QTc interval.
Time frame: At screening (27 days prior to Day -1) through to 11 days post dose for Parts 3a and 3b and at screening (27days prior to Day -1) through to Day 21
Ran from Nov 2017 to primary completion in Nov 2021, 48 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Itraconazole