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
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, see Learn About Clinical Studies.

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 August 28, 2014