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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00813670
First Posted: December 23, 2008
Last Update Posted: September 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Xenon Pharmaceuticals Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813670


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

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
First Submitted: December 19, 2008
First Posted: December 23, 2008
Last Update Posted: September 14, 2009
Last Verified: September 2009