Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Human Volunteers
- Interventions
- Drug: XPF-001
- Registration Number
- NCT00813670
- Lead Sponsor
- Xenon Pharmaceuticals Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Single dose of XPF-001 XPF-001 - Cohort 2: Single dose of XPF-001 XPF-001 - Cohort 3: Single dose of XPF-001 XPF-001 - Cohort 4: Single dose of XPF-001 XPF-001 - Cohort 5: Single dose of XPF-001 XPF-001 - Cohort A: Repeated doses of XPF-001 XPF-001 - Cohort B: Repeated doses of XPF-001 XPF-001 - Cohort C: Repeated doses of XPF-001 XPF-001 -
- Primary Outcome Measures
Name Time Method ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events. up to 14 days post dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Anapharm
🇨🇦Montreal, Quebec, Canada