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
Verified date | September 2009 |
Source | Xenon Pharmaceuticals Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Anapharm | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Xenon Pharmaceuticals Inc. |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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