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

NCT03467100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

XEN901

Capsule filled with XEN901

DRUG

Inert Ingredients Oral Product

Placebo capsule

Sponsors & Collaborators

Principal Investigators

  • Gregory Beatch, PhD · Xenon Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2018-12-19
Completion
2018-12-19

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03467100 on ClinicalTrials.gov