Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN1101
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ClinicalTrials.gov Identifier: NCT03340220 |
Recruitment Status : Unknown
Verified July 2019 by Xenon Pharmaceuticals Inc..
Recruitment status was: Active, not recruiting
First Posted : November 13, 2017
Last Update Posted : July 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: XPF-008 Drug: Microcrystalline Cellulose | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 1, First-in-human, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses of XEN1101 and Preliminary Open-label Pharmacodynamic Assessment in Healthy Subjects |
Actual Study Start Date : | October 16, 2017 |
Estimated Primary Completion Date : | December 1, 2019 |
Estimated Study Completion Date : | December 1, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: XPF-008
Single ascending dose: Single oral dose for each cohort Multiple ascending dose: 7 days of single oral dose daily for each cohort |
Drug: XPF-008
Capsule filled with XEN1101 |
Placebo Comparator: Placebo - Microcrystalline cellulose
Single Ascending Dose: Single oral dose for each cohort Multiple Ascending Dose: 7 days of single oral dose daily for each cohort |
Drug: Microcrystalline Cellulose
Placebo capsule |
- 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 electrocardiogram (ECG) [ Time Frame: At screening (28 days prior to Day 1) through to 7 days post-final dose ]To assess ECG as a criteria of safety and tolerability
- Vital signs [ Time Frame: At screening (28 days prior to Day 1) through to 7 days post-final dose ]To assess vital signs as a criteria of safety and tolerability
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 predose through to 7 days post-final dose ]Cmax is the maximum observed plasma concentration in ng/mL
- Time to the Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 1 predose through to 7 days post-final dose ]Tmax is the time in hours to reach Cmax following dosing
- Terminal elimination half-life (t1/2) [ Time Frame: Day 1 predose through to 7 days post-final dose ]The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase
- 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 7 days post-final dose ]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

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
- Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.50 and 30.00 kg/m2
- Must agree to use effective methods of contraception, if applicable
- Able to swallow capsules
- Able to provide written, personally signed and dated ICF
Key Exclusion Criteria:
- Any history of epileptic seizures
- 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
- Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale
- Mental incapacity or lingual barriers precluding adequate understanding, cooperation, and compliance with the study
- No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end
- No smoking 60 days prior to dosing to study end
- No soft drugs 3 months prior to Screening and hard drugs 2 years prior to Screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340220
United Kingdom | |
Richmond Pharmacology Ltd. | |
London, United Kingdom, SE1 1YR | |
King's College Hospital | |
London, United Kingdom, SE5 9RS |
Study Director: | Gregory N Beatch, PhD | Xenon Pharmaceuticals Inc. |
Responsible Party: | Xenon Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03340220 |
Other Study ID Numbers: |
XPF-008-101a 2017-003168-11 ( EudraCT Number ) C17030 ( Other Identifier: Richmond Pharmacology Ltd ) |
First Posted: | November 13, 2017 Key Record Dates |
Last Update Posted: | July 22, 2019 |
Last Verified: | July 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Transcranial Magnetic Stimulation |