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

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

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 May 19, 2013