Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers

Xenon Pharmaceuticals Inc.64 enrolled

Overview

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers. The effect of food on the pharmacokinetics of XPF-001 will also be studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Human Volunteers

Interventions

XPF-001DRUG

Single oral dose, or 6 days of repeated oral doses.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects (Females of non-childbearing potential) with normal or clinically insignificant laboratory results, ECGs and physical examinations. Exclusion Criteria: * Subjects with a presence or history of any clinically significant disease. * Subjects who have participated in and investigational drug trial within 60 days of admission. * Subjects who have used tobacco or nictoine products in the 1 month prior to admission * Females who are pregnant or breastfeeding

Locations (1)

Anapharm

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.

Time frame: up to 14 days post dose

Data from ClinicalTrials.gov

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