Healthy Male VolunteersPhase 1NCT03468725
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
A Phase 1 study testing XPF-008 and Microcrystalline Cellulose in people with Healthy Male Volunteers, run by Xenon Pharmaceuticals Inc. at 1 site in United Kingdom.
Trial summary
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- XPF-008 and Microcrystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2018to 31 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 signed and dated Informed Consent Form
Who cannot join
- Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
- Any clinically significant abnormalities in vital signs, ECGs, physical examinations, or laboratory evaluations
- Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study
- No prescription or over-the-counter (OTC) medications (including multivitamins, herbal or homeopathic preparations 14 days or if applicable/available, 5 half-lives prior to dosing to study end
- Any history of severe head trauma
- No smoking 60 days prior to dosing to study end
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Administration of XEN1101 in Healthy Male Subjects
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure 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 EMG activity. It is estimated there will be approximately 15 subjects in the planned study.
- Conditions
- Healthy Male Volunteers
- Being tested
- XPF-008, Microcrystalline Cellulose
- Keywords
- Transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPF-008Drug
Capsule filled with XEN1101
Microcrystalline CelluloseDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| XPF-008 | Experimental | Single oral dose Receives: Drug: XPF-008 |
| Placebo | Active comparator | Single oral dose Receives: Drug: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) as assessed by CTCAE v4.03
To assess AEs as a criteria of safety and tolerability
Measured: From screening (28 days prior to Day 1) through to 30 days post-final dose
Resting 12-lead electrocardiogram (ECG)
To assess ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability
Measured: From screening (28 days prior to Day 1) through to Day 14
Number of participants with vital sign abnormalities
To assess vital signs as a criteria of safety and tolerability
Measured: From screening (28 days prior to Day 1) through to Day 14
Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability
To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG
Measured: Day 1 predose through to Day 7
PD Effects assessed by TMS biological markers of brain excitability
To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response
Measured: Day 1 predose through to Day 7
Secondary outcomes (3)
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration in ng/mL
Measured: Day 1 predose through to Day 8
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
Measured: Day 1 predose through to Day 8
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
Measured: Day 1 predose through to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start13 Feb 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Beatch, PhD, Study director, Xenon Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468725
- Sponsor's protocol ID
- XPF-008-101b
- Other IDs
- 2017-003181-27, C17047, 2017
- Status last verified
- Sep 2018
- First submitted
- 2 Mar 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Administration of XEN1101 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03468725
- Acronym / sponsor ID
- XPF-008-101b
- Conditions
- Healthy Male Volunteers
- Keywords
- Transcranial magnetic stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure 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 EMG activity. It is estimated there will be approximately 15 subjects in the planned study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XPF-008 | Experimental | Drug: XPF-008Single oral dose |
| Placebo | Active comparator | Drug: Microcrystalline CelluloseSingle oral dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 signed and dated Informed Consent Form
Key exclusion criteria (6 listed)
- Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
- Any clinically significant abnormalities in vital signs, ECGs, physical examinations, or laboratory evaluations
- Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study
- No prescription or over-the-counter (OTC) medications (including multivitamins, herbal or homeopathic preparations 14 days or if applicable/available, 5 half-lives prior to dosing to study end
- Any history of severe head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPF-008Capsule filled with XEN1101 | Drug | XPF-008 |
| Microcrystalline CellulosePlacebo capsule | Drug | Placebo |
Primary outcome
Number of participants with adverse events (AEs) as assessed by CTCAE v4.03
Time frame: From screening (28 days prior to Day 1) through to 30 days post-final dose
To assess AEs as a criteria of safety and tolerability
Resting 12-lead electrocardiogram (ECG)
Time frame: From screening (28 days prior to Day 1) through to Day 14
To assess ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability
Number of participants with vital sign abnormalities
Time frame: From screening (28 days prior to Day 1) through to Day 14
To assess vital signs as a criteria of safety and tolerability
Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability
Time frame: Day 1 predose through to Day 7
To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG
PD Effects assessed by TMS biological markers of brain excitability
Time frame: Day 1 predose through to Day 7
To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response
3 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 predose through to Day 8
Terminal elimination half-life (t1/2)
Time frame: Day 1 predose through to Day 8
Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)
Time frame: Day 1 predose through to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
Related trials for Healthy Male Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Beatch, PhD study director
Xenon Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XPF-008 and Microcrystalline Cellulose in people with Healthy Male Volunteers, run by Xenon Pharmaceuticals Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) as assessed by CTCAE v4.03 (time frame: From screening (28 days prior to Day 1) through to 30 days post-final dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.