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

Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XPF-001 and to Investigate the Effect of Food on the Pharmacokinetics of a Single Dose of XPF-001 in Healthy Subjects

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 Overview

• Status: Completed
• Conditions: Healthy Human Volunteers
• Intervention / Treatment: Drug: XPF-001

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Anapharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Single dose of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.
Experimental: Cohort 2: Single dose of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.
Experimental: Cohort 3: Single dose of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.
Experimental: Cohort 4: Single dose of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.
Experimental: Cohort 5: Single dose of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.
Experimental: Cohort A: Repeated doses of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.
Experimental: Cohort B: Repeated doses of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.
Experimental: Cohort C: Repeated doses of XPF-001	Drug: XPF-001; Single oral dose, or 6 days of repeated oral doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.	up to 14 days post dose

Collaborators and Investigators

• Sponsor: Xenon Pharmaceuticals Inc.
• Investigators: Principal Investigator: Richard Larouche, MD, Anapharm

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (Estimate): December 23, 2008

Study Record Updates

• Last Update Posted (Estimate): September 14, 2009
• Last Update Submitted That Met QC Criteria: September 10, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: XPF-001-101