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

This study has been completed.
Sponsor:
Information provided by:
Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00813670
First received: December 19, 2008
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Healthy Human Volunteers
Drug: XPF-001
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Xenon Pharmaceuticals Inc.:

Primary Outcome Measures:
  • ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events. [ Time Frame: up to 14 days post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813670

Locations
Canada, Quebec
Anapharm
Montreal, Quebec, Canada
Sponsors and Collaborators
Xenon Pharmaceuticals Inc.
Investigators
Principal Investigator: Richard Larouche, MD Anapharm
  More Information

No publications provided

Responsible Party: Dr. Paul Goldberg, Senior Director Clinical Biology and Target Discovery, Xenon
ClinicalTrials.gov Identifier: NCT00813670     History of Changes
Other Study ID Numbers: XPF-001-101
Study First Received: December 19, 2008
Last Updated: September 10, 2009
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on April 17, 2014