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

Xenon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Human Volunteers

Treatments: Drug: XPF-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813670

XPF-001-101

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 8 patient groups

Cohort 1: Single dose of XPF-001

Experimental group

Treatment:

Drug: XPF-001

Cohort 2: Single dose of XPF-001

Experimental group

Treatment:

Drug: XPF-001

Cohort 3: Single dose of XPF-001

Experimental group

Treatment:

Drug: XPF-001

Cohort 4: Single dose of XPF-001

Experimental group

Treatment:

Drug: XPF-001

Cohort 5: Single dose of XPF-001

Experimental group

Treatment:

Drug: XPF-001

Cohort A: Repeated doses of XPF-001

Experimental group

Treatment:

Drug: XPF-001

Cohort B: Repeated doses of XPF-001

Experimental group

Treatment:

Drug: XPF-001

Cohort C: Repeated doses of XPF-001

Experimental group

Treatment:

Drug: XPF-001