Trials / Completed
CompletedNCT03468725
Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Xenon Pharmaceuticals Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XPF-008 | Capsule filled with XEN1101 |
| DRUG | Microcrystalline Cellulose | Placebo capsule |
Timeline
- Start date
- 2018-02-13
- Primary completion
- 2018-07-31
- Completion
- 2018-07-31
- First posted
- 2018-03-16
- Last updated
- 2018-09-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03468725. Inclusion in this directory is not an endorsement.