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

• Sponsor: Xenon Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00813670
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 8
• Duration (Months): 8
• Patients Per Site Per Month: 8

Study Details

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
• Anticipated 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: Nov 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jul 1, 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. [up to 14 days post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Anapharm	Montreal	Quebec	Canada

Sponsors and Collaborators

• Xenon Pharmaceuticals Inc.

Investigators

• Principal Investigator: Richard Larouche, MD, Anapharm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00813670
• Other Study ID Numbers: XPF-001-101
• First Posted: Dec 23, 2008
• Last Update Posted: Sep 14, 2009
• Last Verified: Sep 1, 2009

Study Results

No Results Posted as of Sep 14, 2009