NCT00813670
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- XPF-001
- Conditions
- Healthy Human Volunteers
- Sponsor
- Xenon Pharmaceuticals Inc.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
Arms & Interventions
Cohort 1: Single dose of XPF-001
Intervention: XPF-001
Cohort 2: Single dose of XPF-001
Intervention: XPF-001
Cohort 3: Single dose of XPF-001
Intervention: XPF-001
Cohort 4: Single dose of XPF-001
Intervention: XPF-001
Cohort 5: Single dose of XPF-001
Intervention: XPF-001
Cohort A: Repeated doses of XPF-001
Intervention: XPF-001
Cohort B: Repeated doses of XPF-001
Intervention: XPF-001
Cohort C: Repeated doses of XPF-001
Intervention: XPF-001
Outcomes
Primary Outcomes
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.
Time Frame: up to 14 days post dose
Study Sites (1)
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