Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2018-12-19

Brief Summary

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The XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. It is estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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XEN901

Single ascending dose: Single oral dose for each cohort; Multiple ascending dose: 7 days of single oral dose twice daily for each cohort

Group Type EXPERIMENTAL

XEN901

Intervention Type DRUG

Capsule filled with XEN901

Placebo

Single Ascending Dose: Single oral dose for each cohort; Multiple Ascending Dose: 7 days of single oral dose twice daily for each cohort

Group Type PLACEBO_COMPARATOR

Inert Ingredients Oral Product

Intervention Type DRUG

Placebo capsule

Interventions

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XEN901

Capsule filled with XEN901

Intervention Type DRUG

Inert Ingredients Oral Product

Placebo capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 32.0 kg/m2
* Must agree to use effective methods of contraception, if applicable
* Able to swallow capsules
* Able to provide written, personally signed and dated Informed Consent Form

Exclusion Criteria

* Any history of 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 language 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
* Any clinically significant abnormalities in vital signs, ECG, physical exam, or laboratory evaluations

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes