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

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ClinicalTrials.gov Identifier: NCT00813670
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : September 14, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Human Volunteers Drug: XPF-001 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
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
Study Start Date : November 2008
Primary Completion Date : May 2009
Study Completion Date : July 2009
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events. [ Time Frame: up to 14 days post dose ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: December 23, 2008    Key Record Dates
Last Update Posted: September 14, 2009
Last Verified: September 2009