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

Healthy Human Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813670
• Other study ID #: XPF-001-101
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2008
• Last updated: September 10, 2009
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Xenon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Human Volunteers

Intervention

Drug:
• XPF-001
Single oral dose, or 6 days of repeated oral doses.

Locations

Country	Name	City	State
Canada	Anapharm	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Xenon Pharmaceuticals Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.		up to 14 days post dose	Yes