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

December 19, 2008
September 10, 2009
November 2008
May 2009   (final data collection date for primary outcome measure)
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events. [ Time Frame: up to 14 days post dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00813670 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Human Volunteers
Drug: XPF-001
Single oral dose, or 6 days of repeated oral doses.
  • Experimental: Cohort 1: Single dose of XPF-001
    Intervention: Drug: XPF-001
  • Experimental: Cohort 2: Single dose of XPF-001
    Intervention: Drug: XPF-001
  • Experimental: Cohort 3: Single dose of XPF-001
    Intervention: Drug: XPF-001
  • Experimental: Cohort 4: Single dose of XPF-001
    Intervention: Drug: XPF-001
  • Experimental: Cohort 5: Single dose of XPF-001
    Intervention: Drug: XPF-001
  • Experimental: Cohort A: Repeated doses of XPF-001
    Intervention: Drug: XPF-001
  • Experimental: Cohort B: Repeated doses of XPF-001
    Intervention: Drug: XPF-001
  • Experimental: Cohort C: Repeated doses of XPF-001
    Intervention: Drug: XPF-001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00813670
XPF-001-101
Not Provided
Dr. Paul Goldberg, Senior Director Clinical Biology and Target Discovery, Xenon
Xenon Pharmaceuticals Inc.
Not Provided
Principal Investigator: Richard Larouche, MD Anapharm
Xenon Pharmaceuticals Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP